Document zzvqNg8Qdep88pGjJ7OzYm23g

TO: Distribution Interoffice Communication FROM: DATE: SUBJ: T. G. Grumbles February 22, 1990 VIS1A OSHA FINAL STANDARD ON OCCUPATIONAL EXPOSURES TO HAZARDOUS CHEMICALS IN LABORATORIES The final standard was promulgated on January 31. It is effective on May 1 of this year, with a final compliance date of January 31, 1991. The basic concept of the standard is the development and implementation of a Chemical Hygiene Plan (CHP). The CHP must include the necessary work work practices, procedures, and policies to ensure that employees are protected from hazardous chemicals in their work area. The CHP content is specifically defined in terms of general areas, such as establishing standard operating procedures, but the standard allows a large measure of flexibility in compliance methods. Applicability of the standard to Vista's laboratories is unclear to me at this time. Much discussion of the applicability of the standard and a relatively elaborate definition of applicability is found in the preamble and standard. The preamble states most manufacturing quality control laboratories probably aren't covered (P. 3312), but it seems our labs probably meet the definition of "laboratory use of hazardous chemicals" (P. 3328) which would cause us to be covered. I will review this with Legal and advise on applicability as well as give you more analysis of the standard in the near future. For now, I've enclosed a copy of the preamble and standard. standard begins on Page 3327. The T. G. Grumbles dlj Attachment VVV 0000111*7 3300 Federal Register / Vot. 55. No. 21 / Wednesday, January 31, 1990 / Rules and Regulations DEPARTMENT OF LABOR i- and information, medical consultation .final rule For review. These remarks are and examinations, hazard identification,, reproduced below, followed by the Occupatfonaf Safety and Hearth respirator use and recordkeeping. To the ; Agency's response.- . ; Administration . 29 CFR Part 1910 extent possible, the standard allows a large measure of flexibility in . - compliance methods. -v: .... Each element of the chemical hygiene pran i 1910.1450(d)(2)(i} through (d){x), shall be completely justified.-This justification shall [Docket No. H-150) R1N 121S-AAOO Dates: Effective Date: This final* rinclude a summary of the comments in the standard published today shall become .in public rulemaking record on each element effective on May 1.1990. -Second, the final paperwork package shall Compliance Date: Employers shall V ' include airestunate of the burden hours - Occupational Exposures to Hazardous,. Chemicals in Laboratories *** * have completed an appropriate . Chemical Hygiene Plan and commenced associated with 5 1910.134. the respiratory protection program, which is referenced in AGENCY; Occupational Safety and Health Administration (OSHA), Labor. * ACTION: Final rule. " " '~'T summary: By this Notice, the - '*r -` * Occupational Safety and Health X ' : X" Administration (OSHA) hereby promulgates a final rule for occupational exposures to hazardous chemicals in carrying out its provisions by January ?. 31,1991. ; - ' addresses: In compliance with 28 ; -yy : U.S.C. 2112(a). the Agency designates for receipt of petitions for review of the " - standard, the Associate Solicitor for r Occupational Safety and Health. Office of the Solicitor. Room S--4004, U.S. - Department of Labor, 200 Constitution X $ 1910.1450(e). Third, the agency shall arrive vat a net change in burden by estimating the '.'reduction in burden resulting from the exemption for laboratories from recordkeeping requirements in the general . industry health standards. Fourth, the burden estimate of five minutes for exposure evaluations and three hours for development of chemical hygiene plans shall be supported by evidence from the record, or shall be : > - laboratories. - Avenue NW., Washington, DC 20210.' ."X .revised accordingly. Fifth, the estimated The basis for this standard is a .. . FOR FURTHER INFORMATION CONTACT:^ L /J current compliance rate of 56 percent for the r- determination by the Assistant : Mr. James F. Foster, Office of X - 7 chemical hygiene plan requirements shall be'" X Secretary, after careful review of the Information and Consumer Affairs, ' - supported by evidence from the record, or : - v complete rulemaking record, that : * Occupational Safety and Health XX ' . shall be revised accordingly. laboratories typically differ from - industrial operations in their use and handling of hazardous chemicals and : that a different approach than that found in OSHA's substance specific Administration, 200 Constitution Avenue NW.f Room N3649, Washington, X DC 20210; Telephone: (202) 523-8151.Xr.'.j' - -The Chemical Hygiene Plan has been.j^t: . redesignated as paragraph (e) in the -.-- ,. : final rule. OSHA believes that it has ... t SUPPLEMENTARY INFORMATION: . 21 ,. ^ sufficient Justification for the inclusion T health standards is warranted to protect Information Collection RequirementsX---; : of each element of the Chemical . . . workers. 1 The final standard applies to all laboratories that use hazardous . . lemicals in accordance with the . -efinition of laboratory use and y' laboratory scale provided in the ]. " standard. Generally, where this v-- -- standard applies it supersedes the x provisions of all other standards in 29 CFR part 1910, subpart Z, except in specific instances identified by this standard. For laboratories covered by ff -- . On March 31,1983, the Office of _"**** Management and Budget (OMB) published a new 5 CFR part 1320, implementing the information collection . . provisions of the Paperwork Reduction ' Act of 1980, 44 U.S.C. 3501 et seq. (48 FR - "13866). Part 1320. which became H___ ^effective on April 30,1983 and was v-f revised on May 10,1986 (52 FR 16618)f:- sets forth procedures for agencies to' Jv follow in obtaining OMB clearance for - information collection requirements. The ' Hygiene Plan including supporting - - _____ comments from the pubtic rulemaking . record. In many cases, however, the XL .._ comments addressed the - ' .' ^appropriateness of the Chemical ' /_ Hygiene in general terms rather than -------- addressing individual elements. The discussion of the Chemical Hygiene Plan . is presented in part VI of this preamble . and includes summarization of : comments in the record regarding specific elements of the Plan. this standard, the obligation to maintain sections of this final standard on - -,.With respect to the burden hours L employee exposures at or below the occupational exposures to hazardous----- associated with the respiratory program permissible exposure limits (PELs] chemicals in laboratories which may . in $ 1910.134, OSHA has assumed zero specified in 29 CFR, part 1910. subpart Z create recordkeeping requirements are hours since the Laboratory Standard is retained. However, the manner in paragraphs (d) Employee Exposure 1 .u. " ' does not itself impose a requirement to . which this obligation is achieved will be Determination; (e) Chemical Hygiene' use respirators. Paragraph (i) concerning determined by each employer through Plan: (f) Employee Information and the use of respirators is included to the formulation and implementation of a Training: (g) Medical Consultations and remind employers of the existing Chemical Hygiene Plan (CHP). The CHP Medical Examinations: (h) Hazard compliance obligation of the Respiratory must include the necessary' work Identification; and (j) Recordkeeping. ' - ' - Protection Standard which is found at 29 practices, procedures and policies to In accordance with the provisions of- CFR 1910.134. Burden hours associated ; ensure that employees are protected - the Paperwork Reduction Act and the ' ' with respirator use are addressed in the - from all potentially hazardous chemicals regulations issued pursuant thereto, * Respiratory Protection Standard. in use in their work area. Hazardous OSHA has submitted the information XX '" Laboratories are exempted in this chemicals as defined by the final collection requirements for this final ' final rule from the explicit requirements standard include not only chemicals standard to OMB for review and has ~ for recordkeeping prescribed in the regulated in 29 CFR part 1910, subpart Z. . been granted approval of those . r'.-^ X substance specific General Industry but also any chemical meeting the . provisions through 10/31/92. The OMB ^Standards, except where a standard definition of hazardous chemical with Control Number is 1218-0131.- LX *-- - specifically includes laboratories. respect to health hazards as defined in Concurrent with granting approval of '. However, the Laboratory Standard OSHA's Hazard Communication the information collection requirements : = '-includes In paragraph (d). requirements, ' Standard. 29 CFR 1910.1200(c). , 'X . . ; for the proposed standard. OMB "i-rX- - under certain conditions, for complying . Among other requirements, the final attached remarks which it requested the':; with exposure monitoring of other standard provides for employee training Agency to address when submitting the - ' standards. Similarly, medical tpe-2$; . ' , V wv 000011148 Federal Register / Vol. 55. No. 21 / Wednesday. January 31. 1990 / Rules and Regulations 3301 consultation and medical examinations comments regarding this burden > - Whenever a rule promulgated by the provisions appear in paragraph (g). Employers are required to establish and maintain for each employee .; accurate records of any exposure measurements and any medical- . consultations or examination results estimate or any other aspect of this collection ofinformation, including suggestions for reducing this burden, to the Office of Information Management Department of Labor. Room N-1301, 200 Constitution Avenue NW., Washington, Secretary differs substantially from an existing national consensus standard, the Secretary shall at the same time, publish in the Federal Register a statement of the reasons why the rule as adopted will better effectuate the purposes of this Act than the national consensus standard. performed under this standard. Thus, OSHA's estimate of.the burden hours associated with the recordkeeping . requirements under the Laboratory Standard does not represent a reduction in burden as a result of exempting , laboratories from the recordkeeping . provisions of the General Industry ' Standards. . ,, The burden estimate of five minutes for an exposure evaluation included in the proposed standard is no longer relevant since this requirement has been DC 20210: and to the Office of Management and Budget, Paperwork Reduction Project (1218-0131), Washington, DC 20503. - Table of Contents I. Pertinent Legal Authority \ ,. J... II. History of-the Regulation ; -- III. Significance ofRisk IV. Summary of Regulatory impact ' ' Assessment Regulatory Flexibility Assessment and Environmental Impact Assessment V. Summary of Major Differences Between For the most part, all of the subpart 2 standards will be superseded far laboratories except as noted below. This standard better effectuates the purposes of the Act because it acknowledges the unique characteristics of the laboratory workplace and reflects a more reasonable approach to regulating toxic substances in the laboratory than the approach taken in the General Industry standards in 29 CFR part 1910, Subpart Z. Many of the standards in subpart Z deleted in the final standard. The the Proposed and Final Standard were national consensus standards. This burden estimates associated with the VL Summary of Issues and Explanation of standard does not eliminate the development of chemical hygiene plans as presented in the proposed standard have been revised upward for small and medium size laboratories. The proposed standard estimated that 2, 5, and 8 Provisions of the Final Standard ____ Paragraph (a) Scope and Application Preemption by Other OSHA Health Standards Facilities Chemicals .L'. . requirement to maintain exposures below the applicable PELS and, therefore, does not reduce worker protection but provides greater flexibility in the methods of achieving it hours, respectively, for small, medium Paragraph (b) Definitions Authority to issue this standard is and large laboratories would be Paragraph (c) Permissible exposure limits also found in section 8(c) of the Act. In required to develop chemical hygiene plans. Comments to the record (see e.g. Tr. 80 and Tr. 152) indicated that additional time might be required for chemical hygiene officers to acquaint themselves with proper chemical Paragraph (d) Employee exposure determination Paragraph (e) Chemical hygiene plan Paragraph (f) Information and training Paragraph fg) Medical consultation and medicaL examination Paragraph (h) Hazard identification general, this section empowers the Secretary to require employers to make, keep, and preserve records regarding : ' activities related to the Act. Provisions of OSHA standards which require the making and maintenance of records of hygiene. OSHA believes that the , Paragraph (i) Use of respirators medical examinations and the like are additional time is reasonable, Paragraph (j) Recordkeeping - issued pursuant to section 6(c) of the particularly for small and medium size laboratories. OSHA has therefore1 revised its estimate of the burden hours in connection with the development of chemical hygiene plans to eight hours for all laboratories, regardless of size. Paragraph (k) Dates Effective date Start-up date ; Paragraph (1) Appendices VII. Federalism and State Plan Applicability VIII. Authority The Standard Act. The Secretary's authority to issue this standard is further supported by the general rulemaking authority granted in section 8(g)(2) of the Act. This section empowers the Secretary to "prescribe ' OSHA estimates that approximately 67 percent of all laboratories that would be affected by the final standard are currently in compliance with the chemical hygiene plan requirements. This estimate Is based on information generated in a survey of potentially affected laboratories conducted by Booz, Allen and Hamilton under contract to the Agency (Ex. 7-11). OSHA received no comments to indicate that the compliance rates for chemical Hygiene plans for individual laboratory sectors that were presented in the Preliminary Regulatory Impact Appendix A: National Research Council Recommendations Concerning Chemical Hygiene in Laboratories Appendix B: References . ; I. Pertinent Legal Authority Authority for issuance of this standard is found primarily in sections 6(b). 0(c), and 8(g)(2) of the OSH Act, 29 U.S.C. 635(b), 657(c), and 657(g)(2). Section 6(b)(5) governs the issuance of occupational safety and health standards dealing with toxic materials or harmful physical agents. Section 3(8) of the Act, 29 U.S.C 652(8), defines-an such rules and regulations as he may deem necessary to carry out (hisj responsibilities under [the] Act," in this case as part of, or ancillary to. a section 6(b) standard. The Secretary's ' responsibilities under the Act are defined largely by its enumerated purposes, which include: Encouraging employers and employees in their efforts to reduce the number of occupational safety and health hazards at their places of employment, and to stimulate employers and employees to institute new and to perfect existing programs for providing safe and healthful working conditions (29 Assessment were not accurate estimates. , - Public reporting burden for this collection of information is estimated to average, in the first year of compliance, 8 hours per laboratory, including the ume tor reviewing instructions, searching existing data' sources,' ' gathering and maintaining the data occupational safety and health standard as: (A] Standard which requires conditions, or the adoption or use of one or more practices, means, methods, operations, or processes, reasonably necessary or appropriate to provide safe or healthful employment and . places of employment - - This standard is also issued pursuant U.S.C. 651(b)(1)): Authorizing the Secretary of Labor to set mandatory occupational safety and health standards applicable to businesses affecting interstate commerce, and by creating an Occupational Safety and Health Review Commission for carrying out adjudicatory ' functions under the Act (29 U-S.C. 651 (b)(3)); Building upon advances already made through employer and employee initiative for .needed, and completing and reviewing - to section 6(b)(8) of the Act. This section providing safe and healthful working . the collection of information. Send provides as follows: * i * conditions (29 U.S.C. 651(b)(4); vvv 000011149 3302 Federal Register / Vol. 55. No. 21 / Wednesday. January 31, 1990 / Rules and Regulations Providing for the development and: - - personnel: and in the absence of an .- entitled. "Occupational Exposures to promulgation of occupational .safety acd health standards (29 LLS.C. 651 (bt(9)fc .... ... Providing for appropriate reporting procedures * * * which procedures will help achieve the objectives of th Act and accurately describe the nature of the occupational safety and health problem (29 U.S.C. 651 (b](12)]; Exploring ways to discover latent diseases, exemptionorotherspecial . Toxic Substances in Laboratories" (51 consideration, the standard would FR 26660). OSHA received 129 ebstruct important research, including comments in response to the NPRM. cancer research (39 FR 3756.3759. The NPRM also invited requests for January 29.2974}.. . an informal public bearing. Two While the final standard (39 FRat r i. requests were received: Uni ted Steel 3759) did include some provisions for - - Workers of America. (Ex. 6-38} and the laboratory use of these substances Standard Oil Company (Ex. 8-42). establishing causal connections between (see, for example, 39 FR at 3787.3790), A public bearing, conducted under... diseases and worfc in environmental conditions* * *(29U.S.C.kSl(b)(6n; ' Encouraging joint labor-management efforts to reduce injuries and diseases arising out of employment [29 U.S.C. 65I(b)(l3)): and Developing innovative methods, techniques, and approaches for dealing with occupational safety and health problems (29 U.S.C. 651M5J). Because the laboratory standard La reasonably related to these statutory goal, the Secretary Ends this standard necessary and appropriate to carry out his responsibilities under the Act. . . II. Background and History of the Regulation Since the early eighties. OSHA has been involved in efforts directed toward formulating a special regulatory approach to control occupational exposures to hazardous chemicals in laboratories. Prior to the promulgation of this final rule, laboratories were subject to all provisions of OSHA's General Industry Standards codified in 29 CFR part 1910. subpart Z. However, interested parties involved in laboratory operations have for some time opposed this arrangement. Through their participation in rulemaking proceedings for certain OSHA health standards, various interest groups have indicated that the Agency's approach to standards development did not result in standards that were relevant to laboratories and were not these provisions were later vacated on : OSHA's procedural regulations for procedural grounds. See Synthetic . . rulemaking (29 CFR part 1911). was held Organic Chemical Manufacturers from March 24-28,1987 in Washington. Association v. Brennan. 503 F2d 1155, DC. The hearing was presided over by 1160 (CA 3,1974). cert den. 420 U5.973 Administrative Law Judge Glenn R. (1975). reb. den. 423 ILS. 886 (1975). See . Lawrence. All participants who had also SOCMA Brennan, 508 F2d filed appropriate Notices of Intent to 335^92 (CA X 1974. cert den. 423 US. Appear at the hearing were given the 630 (1975). opportunity to present oral testimony Similar objections were raised by and question other witnesses. laboratories in response to OSHA's The 3-day hearing generated some 400 Cancer Policy (45 FR 5001,5202, january pages of testimony from a number of 22,1980). Again. OSHA considered the interested parties. The post-hearing concerns expressed by the laboratory comment period during which hearing community. While laboratories were participants were permitted to submit included under the scope of the Cancer additional data to the record was Policy. OSHA reserved the right to ; revisit the issue and. if warranted, to waive or modify procedures related to laboratories regarding a specific potential occupational carcinogen. (See originally scheduled to close on june 9. 1987. However, in response to a request for additional time by one of the participants (Ex. 37). Judge Lawrence extended the post-hearing period until 45 FR at 5202). .' Concerns regarding the impact of the Cancer Policy on laboratory operations prompted the formation of informal groups of laboratory experts to study the - problem further. OSHA met with members of one such group, -- representing a cross section of various types of laboratory disciplines in - government, industry and academia. OSHA also met with members of July 30,1987. Twenty submissions were received during this period. The public record for the proposed rule was certified by Judge Lawrence on May 16,1988. All materials submitted to the OSHA Docket Office. Docket No. H150. either by OSHA or the public are contained In the record. ' Copies of the official list of entries to the record and the exhibits are available professional organizations representing from the OSHA Docket Office. Docket clinical laboratories. Input received from No. H-150 Room N-2625. U.S. these groups was carefully considered.' As a result, OSHA decided that further Department of Labor, 200 Constitution Avenue NW,, Washington, DC 20210: investigation into the problems related Telephone: (202) 523-7894. focused on typical exposure conditions . to occupational exposure to toxic and in laboratories. As a result they argued ' hazardous substances in laboratories that laboratories were required to was warranted. comply with provisions that were more On April 14.1981, OSHA published a* appropriately designed for industrial Request for Comment and Information workplaces. concerning health hazards of toxic Objections regarding the substances in laboratories (46 FR 21785). inappropriateness of applying OSHA's This action was taken to gain further health standards to laboratory insight into the problems OSHA health operations began to surface in 2973, standards might pose for laboratories. III. Significance of Risk OSHA included a discussion of significant risk in the preamble to the proposed standard. Jn that discussion OSHA reviewed the relevance of the Supreme Court's Benzene Decision (Industrial Union Department v. American Petroleum Institute. 448 U.S. . 607 (1980}) to the proposed standard. when OSHA began rulemaking for 14 Interested parties were Invited to submit In the Benzene decision, the Court specified carcinogens (29 CFR comments, views and data concerning said that section 3(8) of the Act applies 1910.1003-1910.1004.1910.1006- issues which OSHA needed to address to all permanent standards promulgated 1910.1016; one standard was in deciding whether a special laboratory under the Act and requires the subsequently vacated). The preamble to policy was necessary. Some 200 Secretary, before issuing any-standard. the standard regulating those comments were received in response to - to determine that it is reasonably - substances noted the following this Notice,: : -r;ii necessary and appropriate to remedy a objections from parties representing On July 24,1986. on the basis of significant risk of material health. - laboratories interests: Laboratories use information received in response to the ' Impairment-...-'..: very small amounts of thesubstances; - Request for Comments and other . The "significant risk" determination laboratory work is done by. or under the considerations, OSHA published a- *' constitutes a finding that absent the direct supervision ot highly trained ; notice of proposed rulemaking (NPRMJ change in practices mandated by the- VVV 000011150 Federal Register / Vol. 55, No, 21 / Wednesday, January 31, 1990 / Rules and Regulations 3303 standard, the workplaces in question exercise likely to be impossible to similar safety and health programs (see would be "unsafe" in the~aense that perform. OSHA's significant risk finding Exs. 3-35, 3-36 and 3-133). These workers would be threatened with a for this standard is based on the comments indicate that there may be significant risk of harm. Id. at 642. A - following factors: Epidemiological significant risks associated with significant risk finding, however, does information relating to disease and- chemicals to which laboratory personnel not require mathematical precision or mortality rates among chemists; are exposed. anything approaching scientific evidence from other OSHA rulemaking The preamble to the proposed certainty if the ``best available . proceedings which show significant standard cited five studies on the long evidence" does not warrant that degree risks for specific substances which are - term effects of exposure to toxic of proof. Id. at 655-656; 29 U.S.C. used in the laboratory workplace; the. substances in the laboratory (51 FR at 655(b)(5). Rather, the Agency may base general recognition by the regulated 26665). A study by Li et aL (Ex. 7-3). its finding largely o*n policy community that safe work practices are - "Cancer Mortality Among Chemists." considerations and has considerable necessary to prevent adverse health : was based on data from 3.637 members leeway with the kinds of assumptions it . effects; case report information about . of the American Chemical Society who applies in interpreting the data i, . adverse health effects resulting from died between 1948 and 1967.'Li found a supporting it. Id. ... ^... . .. . . exposures to substances commonly used significantly higher proportion of deaths After OSHA has determined that a in laboratories; and relevant policy : from cancer among male chemists ages significant risk exists and that such risk considerations. -- . 20-64, and age 64 and older, as ' cun be reduced or eliminated by the In the absence of safe work practices. compared to professional men in proposed standard, it must set the . exposure to hazardous chemicals in the general. Li stated: "Though noi standard "which most adequately laboratory presents a significant risk of conclusive, [the study] raises the assures, to the extent feasible, on the material health impairment None of the possibility that occupational exposure of' basis of the best available evidence, comments submitted to the record - chemists increases their risk of * that no employee will suffer a material indicates that hazardous chemicals do lymphoma and pancreatic cancer." impairment of health * * # ""-(section not pose a risk to laboratory workers. If Robert Olin, of the Royai School of 6(b)(5) of the Act). The Supreme Court OSHA's health standards that now Technology, Stockholm, has done has interpreted this section to mean that - apply to laboratories were withdrawn it several studies of disease and mortality OSHA must enact the most protective is clear that the risk would increase. among Swedish chemists. In a 1976 standard possible to eliminate a OSiiA's intent in this standard is to study (Ex.' 7--4), "Leukemia and significant risk of material health reduce significant risk by at least as Hodgkin`9 Disease Among Swedish impairment, subject to the constraints of much as current standards do. while Chemistry Graduates," he traced 517 technological and economic feasibility. - regulating in a manner more appropriate graduates: 58 had died. 22'from cancer, American. Textile Manufacturers to laboratories. Because the working which were nine more than expected. Institute, Inc. v. Donovan; 452 U.S. 490 . conditions and exposures are of a - - Six cancer deaths were due to malignant (1981). The Court held that "cost-benefit different nature than those in general : lymphomas or leukemias, a significant analysis is not required by the statute T"- industry, the hazards should be : increase over the 1.7 deaths expected - because feasibility analysis is "Id. at - . regulated in a different way. 1 . * from this cause. Olin noted a somewhat 509. ,-.v V v y?,.- . The fact that many laboratory lower than expected incidence of lung OSHA has begun to develop a . - employers have implemented some type cancer. Olin tried to investigate the type systematic approach to significant risk of work practices to control employee and extent of chemical exposure in the determination. This approach was exposure to hazardous chemicals in cohort by asking a senior professor to introduced in the publication of the general and carcinogens in particular, distinguish between persons who had - significant risk determination for arsenic indicates the recognition of a potentially done any type of laboratory work ' (48 FR 1864, January 14,1983). OSHA unsafe work environment. Many ("chemists") and those who had not identified, in the arsenic case. five corporations, academic institutions and ("non-chemists"). All but one of the 22 factors, that comprised the basis of a government agencies have devised cancer deaths occurred in the "chemist" significant risk determination. Those detailed guidelines for the handling of group and Olin concluded:' "[It] strongly factors were relevant to evaluating risks hazardous chemicals (see. for example, suggests that the difference in the associated with specific substances. Exs. 3-2, 3-50, 3-77 and 7-i). In neoplasm death rates of the two groups This standard, however, concerns risks particular, they have given carcinogens is at least partly attributable to work in :.in the laboratory workplace which could and suspected carcinogens special chemical laboratories." result from a large variety of substances treatment. Another study by Olin (Ex. 7-5). "The or work conditions. Therefore,. OSHA In the preamble to the proposed Hazards of a Chemical Laboratory believes the methodology used in the standard (51 FR at 26665), OSHA noted Environment: A Study of the Mortality ; arsenic risk determination may not be . that several commenters who have of Two Cohorts of Swedish Chemists," fully applicable for this standard. active safety and health programs (see, indicated a tendency toward a lower ' This is a generic laboratory standard. for example, Exa. 3-79, 3-83, and 3-108) overall death among chemists, but a . Laboratories generally have many. , indicated that their records show the higher mortality rate due to tumors. An hazardous chemicals present to which absence of risk in their laboratory increase in mortality due to leukemia, exposures are intermittent rather than a operations. OSHA believes that these malignant lymphomas or urogenital few substances to which, there are records really attest to the effectiveness tumors and possibly brain tumors was regular exposures. Therefore the of programs such as the Chemical observed. Olin stated: "It is probable appropriate consideration is whether a Hygiene Plan required by this final rale that employment in a chemical significant risk would be present in in reducing the risks due to inherent - laboratory, and particularly in organic laboratories without good laboratory - hazards associated with laboratory - chemistry, is associated to some extent practices rather than-development and work (see Exs. 3-29, 3-64. 3-145 and 3-- with the increase." A follow-up study by . consideration of risk assessments for . 174). In contrast, OSHA also notes the . Olin published in I960 revealed similar hundreds of chemicals present, an comments of organizations without findings. (Ex. 7-6). VVV 000011151 3304 Federal Register f Vol. 55. No. 21 / Wednesday, January 31. 1990 / Rules and Regulations A study by Sheila K. Hoar (Ex. 7-7], "A Retrospective Cohort Study of Mortality and Cancer Incidence Among Chemists." was based on data from employees of the DuPont Company from 1964-1977. This study indicated that ' male chemists experienced a lower overall mortality rate than other salaried employees at DuPont Chemists appeared to have a higher risk of death from malignancies of the colon, cerebrovascular disease and a higher incidence of melanoma and prostate cancer than non-chemists. Chemists, however, had a lower rate of iung cancer than non-chemists. Hoar noted that anticipated excesses of certain types of cancer shown in other studies were not observed "possibly because of the use of absolute mortality rates [rather than proportional rates], inadequate length of follow-up.. exposure to hazardous chemicals by the referent group, or restriction of case identification to active employees." The Hoar study indicated, in general, less of a risk associated with Working in laboratories than did the other studies.. The Hoar study further pointed out that if the results of the other studies, expressed as proportional rates, were adjusted to show standardized mortality rates, apparent differences would be smaller but still present. Another explanation for the difference could be that DuPont followed better laboratory practices than did the laboratories covered by the first three studies. OSHA believes, based on the known existence of hazardous substances in laboratories, the probability of risk associated with the results of the foregoing studies, and evidence from other OSHA rulemaking proceedings, that there is sufficient evidence of significant risk of material health impairment to workers not protected by an appropriate standard to justify this standard under the OSH Act. Although OSHA does not believe it is necessary to demonstrate' significant risk on a substance by substance basis, it is useful to focus on some of the substances currently regulated by OSHA for which a significant risk determination has been or could be made. The fact that many laboratory workers are exposed to these substances supports the general significant risk showing for laboratories. In the benzene decision, the Supreme Court noted that: "In other proceedings, the Agency has had a good deal of data from animal experiments on which it could base a conclusion on the significance of risk." 448 LLS. at 657. n. 64. The Court then referred to findings in the rulemaking record for vinyl chloride. and bis chloromethyl ether. An showed that in some instances, a health extension of the Court's reasoning - hazard did exist to employees exposed .indicates that findings for some of the to certain of these substances. Major xther substances regulated in the 1974 contributors to the hazardous conditions carcinogen standard also form a included ineffective exhaust ventilation sufficient basis for a significant risk and poor work practices (Ex. 7-8). determination. For example, benzidine An article in International Laboratory was demonstrated to be a carcinogen in cites examples of injury from hazardous experimental animals and. by virtue of chemical exposure in the laboratory epidemiologic investigations, which range from dermatitis to fatal carcinogenic in humans. Epidemiological pulmonary edema. The author, a studies conducted by Melick el al. and research chemist with the Centers for Koss el al. have established die Disease Control, U.S. Department of potential of4-aminodiphenyl to induce Health and Human Services, explains bladder cancer in humans. that these examples demonstrate at Recent studies on ethylene oxide least three important points: indicate significant risk at levels as low as 1 part per million parts of air over a working lifetime. (Final standard for First exposure to toxic agents in the laboratory can have severe consequences. Including death: second, these injuries can Ethylene Oxide, (49 FR 25734, June 22. occur in any type of laboratory where toxic 1984).] OSHA has determined that a significant risk of material health impairment exists in the event of overexposure to many of the specific substances it regulates. The fact that ~ many of these substances are also used in laboratories provides a potential for significant risk to laboratory workers; The preamble to the proposed standard also included case reports as evidence of hazardous chemical exposures in laboratories (51 FR at 26666). In particular, it cited the results of a 1979 survey pertaining to xylene exposures among members of the California Association of Cytotechnologists. (CC) (Ex. 3-41). The problems noted among the 70 respondents to the survey included inadequate ventilation (59%); lack of an exhaust system (22.6%); and lack of inspection of the exhaust system (43%). The comment submitted by the CAC also included an article by Roberta N. Hipolito which documents five case studies of xylene poisoning in laboratory workers. A xylene study of 71 workers in 15 laboratories indicated that there were 170 health complaints chemicals are handled: and third and most important, most all of the Injuries are preventable. If these people had had the proper equipment if they had been using the proper techniques and if they had had , adequate knowledge, these exposures probably would not have occurred. (Ex. 7-9]. During the public bearing on the proposed laboratory standard. Dr. Jay Young, a chemirsd safety consultant specializing in laboratory safety, died - several examples of risks confronting -- laboratory workers. Dr. Young's examples were gleaned from the Manufacturing: Chemists'Association (MCA) compilation of case histories of accidents or near-accidents occurring in the chemical industry, including those occurring in laboratories. The MCA case histories were based on inddents - voluntarily reported by member companies between 1951 and 1977. In presenting particular accident case histories. Dr. Young also stated that provisions prescribedin the proposed standard would have prevented such incidents. For example, regarding MCA Accident Case History No. 238. Dr. - Young stated; among the group: In addition. 45.5% felt A control laboratory analyst was exposed that they had experienced significant to hydrogen cyanide, an extremely toxic gas, exposures to xylene and 14% considered changing jobs due to xylene exposure. Health hazard evaluations conducted by the National Institute for because there was no provision in her operating procedures to protect (against) such exposure. Fortunately, in this instance she recovered after a short hospital stay. Clearly, a [Chemical Hygiene Flan] conforming to the Occupational Safety and Health (proposed standard] would have established (NIOSH) present further evidence of the- standard operating procedures that would risk associated with hazardous have mandated the use of engineering chemicals in laboratory operations. NIOSH was requested on several controls to prevent a near-fatal exposure, (Tr. 66.) occasions to evaluate employee . exposures to xylene, formaldehyde, chloroform, toluene and methyl methacrylate in histology, cytology and surgical pathology laboratories following employee complaints of respiratory and behavioral problems. The result of these investigations Dr. Young also presented MCA Accident Case History No. 34; A carbon monoxide cylinder ruptured causing the death of the laboratory wort er who was either connecting or disconnecting the cylinder to a gas line. Probably, the rupture was caused by contamination of high pressure carbon monoxide with air. A CHP VVV 000011152 Federal Register / Vol. 55, No. 21 / Wednesday, January 31. 1990 / Rules and Regulations 3305 with provisions for suitable chemical safety instruction would have prev&oiea this incident. (Tr. 65.J Additional evidence supporting the * significant risk argument was noted in the testimony of Diane Factor of the AFL-CIO. According lo Ms. Factor, her first encounter with health hazards in the laboratory came when she was a . chemistry student and part-time laboratory assistant. Ms. Factor said, "As I sat in the stockroom of the laboratory during quiet hours, i would . read toxicology texts and was surprised to learn that several of the substances we routinely handled in the lab were extremely toxic." Ms. Factor said that she became particularly interested in the potential exposure to mercury, because of the tendency of beginning chemistry students to break thermometers. The visible evidence of the presence of mercury in areas of the laboratory . prompted her to bring the problem to the attention of one of her professors who, subsequently, conducted instrumental monitoring which showed high levels of mercury vapors in the laboratory * classrooms and stockroom. Because of. Her concern for a safe laboratory environment. Ms. Factor said that she was assigned to clean up the labs. As she testified. "In that process, I discovered a laundry list of problems-- improper storage of chemicals, as explosive as picric acid, leaking drums. incompatible storage, lab hoods that did not function, incorrect disposal of solvents and metal and friable asbestos." As she stated further: `The correction of these problems was expensive and time consuming but was accepted by the supervision of the department because they realized that I had uncovered a virtual time bomb." (Tr. 460-461). Ms. Factor, an industrial hygienist, was also previously employed by CAL OSHA as a field inspector for five years, during which time she had many opportunities to inspect various types of laboratories. Ms. Factor also related some of her experiences in inspecting laboratories during her employment at CAL OSHA which included the lack of properly functioning hoods and make shift laboratories without any ventilation (Tr. 462). Dr. Daniel Teiteibaum. Director of Medical Toxicology at Denver Clinic Medical Centers also testified regarding lhe inherent risks associated with laboratory work. He stated: In my view there are common risks and responsibilities in laboratories, no matter '''hat their mission. The common risks arisenorn the need to carry out exacting and frequently dangerous procedures at the siting edge of the laboratory discipline. The common responsibility requires that the best avoid such-effects. Compliance with the possible working conditions and safest general industry standards should be possible environment is provided in which to sufficient so that any residual risk is carry* put the analytical and experimental insignificant * * * (8-12). procedure. Only in this fashion can we assure that tha laboratory* scientist is not harmed by In the case of this latter submission. his or her work. (Tr. 48.) - OSHA believes that the commenterdid In addition to the risk posefl by exposure to individual hazardous chemicals in die laboratory, workers are often exposed to a mixture of hazardous substances which may produce a variety of toxic reactions. In particular, such reactions may be additive or synergistic. This situation was recognized by the' American Conference of Governmental. Industrial Hygienists (ACGIH) in 1963 when it adopted its formula to compute exposure to chemical mixtures. OSHA incorporated this formula into its air contaminants standard. 29 CFR 1910.1000(d)(2)(i) in 1971. Because such mixed exposures may ' be more common in laboratories than in most other workplaces (see. for example, Exs. 3-27,3-29,3-107). not fully consider the guidance indicated in the benzene decision for establishing a finding of significant risk. In accordance with the Court's ruling. OSHA feels that it has in fact presented the "best available evidence" of the risks associated with laboratory operations. As the Standard Oil comment pointed out the studies cited in the preamble to the proposed standard on long term health effects of exposure to toxic substances iri laboratories (Ex. 7-3 through Ex. 7-7) were not conclusive. However. OSHA believes that the result of the studies indicate that the increase in mortality- rates among chemists is partially attributable to work in chemical laboratories. ' possible synergistic effects could pose a OSHA agrees with the Standard Oil greater risk to laboratory workers than the risk posed to workers exposed to the same substances singly. Based on the factors discussed above-. comment insofar as it states that the mere presence of an OSHA regulated substance in a laboratory should not designate it as an unsafe workplace. The OSHA feels that exposure to hazardous point intended (at 51 FR 26665) was that chemicals in laboratories poses a laboratories commonly use OSHA- significant risk of material health impairment, in the absence of the safe work practices and other provisions of - regulated substances for many of which a finding of significant risk has been clearly established. The use of such this standard. Therefore, the provisions substances in the laboratory', in the of this standard are reasonably . necessary to reduce or eliminate that absence of protective measures, including those required by OSHA's significant risk. current standards, increases the risk of OSHA solicited comment on the material health impairment. arguments it presented regarding risk OSHA's objective in this standard is determination in the proposed standard. to reduce the significant risk by at least Two comments were received. as much as do its current health Thomas Evans. Director of Safety and standards but in a manner which is Environmental Health for Monsanto (Ex. more appropriate and cost effective for 8-36) concurred with OSHA's position laboratories. Laboratory operations that risk determinations in laboratories involve a greater variety of potential must consider the nature of the hazards than do most workplaces. laboratory work and reflect the variety , Hence, effective employee protection of materials and operations associated with a typical laboratory. requires precautions and work practices not usually found in other work Standard Oil presented an opposing environments. view: Since OSHA's health standards are With respect to the bases for the significant risk finding, Standard Oil believes that (a) the referenced disease and mortality rate studies are non-condusive. (o) the mere presence of designed primarily to control exposures to a single substance that is used constantly and usually in large quantities, they do not adequately an OSHA regulated chemical substance in address the risk associated with the use the laboratory should not be used to of multiple hazardous substances as is designate or itnolv an unsafe workplace and (c) safe work practices are both needed and used to control Employee exposure to chemical substances, but it is inappropriate for OSHA to use this as a basis for their finding of significant risk. With regard to case reports of adverse- typically the case in the laboratory workplace. Because of the multiple chemicals used by laboratories. OSHA is unable to develop a traditional type of quantitative risk assessment However. OSHA believes that anecdotal health effects. there is absolutely no information such as that cited in the demonstration that the proposed preamble to the proposed standard requirements would have been necessary to demonstrates that hazardous situations, VVv oooiU5i . 3308 Federal Register / Vol. 55, No. 21 / Wednesday, January 31. 1990 / Rules and Regulations and thus, potentially significant risks, Impact and Regulatory Flexibility can exist in laboratories. In many of Assessment for the standard to control these cases, OSHA believes that the occupational exposures to hazardous need for employee protection such as "chemicals in laboratories. This that afforded by the final laboratory assessment includes a profile of the standard is clearly evident. universe to be covered by the standard, OSHA therefore concludes that a . an estimate pf the costs of compliance significant risk exists in laboratories with both the existing health standards that do not implement work practices applicable to laboratories and this and procedures which are at least as standard, assessment of the economic effective as those prescribed by this and technological feasibility of the new final laboratory standard. standard, and an estimate of the IV. Summary of the Regulatory Impact Assessment Regulatory Flexibility . Assessment and Environmental Impact Assessment potential benefits expected to accrue to laboratory employees,. ; . ' The Secretary has determined that this action would not be a "major rule" as defined by section 1(b) of Executive Executive Order 12291 (46 FR 13197; Order 12291 as it will not have an February 19,1981) requires that a - annual effect on the economy of $100 - regulatory analysis be conducted for ; million or more, cause major increases any rule having major economic - in costs or prices, or have any other consequences on the national economy, : significant adverse effects. OSHA has individual industries, geographical . also determined that this action will not regions, or levels of government. In - have a significant adverse impact on a addition, the Regulatory Flexibility Act substantial number of small entities as of 1980 (Pub. L. 96-353, 93 Stat. 1164 (5 defined by the-Regulatory Flexibility U.S.C. 601 e;se<7.)) requires the Act. Occupational Safety and Health Administration (OSHA) to determine Summary of Industry Profile and Costs whether a new regulation will have a - The rulemaking record indicates that , significant economic impact on a the Laboatory Standard could ` substantial number of small entities. potentially affect 934,000 employees in Consistent with these requirements, 34,214 laboratories. Laboratories that OSHA has prepared a Regulatory . v - - would fall within the scope of this - standard can be classified generally as industrial, clinical, and academic. Within these major categories. subcategories have been established for the purpose of determining potential impacts. In this industrial sector, there are approximately 10,000 captive research and development (R&D) and testing labs, and 2.500 independent labs in the industrial category. Of the clinical labs, there are about 7,100 in hospitals, and 7,600 independent labs. In the academic sector, there are about 1,200 labs in private post secondary schools, .5,600 in private secondary schools, and , 214 in private professional schools. - OSHA has examined the annuaiized costs-(in 1987 dollars) of compliance for the Laboratory Standard, and for - comparison, the costs that would exist if - _ laboratories remained covered under the General Industry health standards. " These costs were estimated for all affected laboratory categories and were calculated from a baseline of current compliance levels. These estimates are displayed in Tables I and 11. Costs are broken out for each lab sector and by the standard's provisions, such as the development of Chemical Hygiene Plans,, employee training, personal monitoring, medical surveillance.-and protective clothing. BILLING CODE 4S10-2S-M ` :` - i ' ' - VVV 000011154 /Federal Register / Vol. 55, No. 21 / Wednesday. January 3 1 .199Q Rules and Regulations_______ 3307 TABLE I ANNUAL COST OF COMPLIANCE WITH GENERAL INDUSTRY STANDARDS (J) Lab Type Written Plans Training Personal Monitoring Hood ' Monitoring & Maintenance Medical Sflrveil- lance Closed Containers Respirators RecordKeeping Change Rooms Showers * Lunch Rooms Hazard ' Signs TOTAL . INDUSTRIAL - . Indep. Test . Captive R&D CLINICAL Hospttal Ind. Practice 30.3S0 101.900 86.194 92,264 75,100 0 287,675 2,627,500 0 584,117 0 396.416 633.525 0 1 0 1,348.164 360.000 ^70,000 1.525 0 42.825 107.100 . 42.425 194,500 0 204,288 . . 17,324 ' 167,276 18,544 162,716 - 27.6)9 18.848 720.950 3.304.400 26.300 2,220,675 : 226,600 7,3^8.000 ' / 0 1.917,784- 80,443 : 962,973 61,484 4,220.508 ACADEMIC Post Secondary Secondary Professional 16.992 75,544 2.598 1.122.396 446,208 443,500 386,256 184,128 298,753 TOTAL X of total 411.642 2,067,204 l.BX 9. OX 4,764.845 20.6X 1,710.504 1.419.096 0 514,800 616,000 66.285 '5.111.289 2,551.373 22. IX 11. OX 3,216/ 34.160 2.925 57,816 239,792 64,151 77,694 841,676 1 0.3X 3.6X ' 149,316 19,824 419.397 0 24,756 3,986,052 0 18,144 3,052,696 o 24,764 1,342,373 . 871,929 5.943,134 462,491 23.123,477 . 3.8X . ' 25,7% 2: OX 100.OX : Source: 8ooz, Allen & Hamilton; U.S. Department of Labor. Occupational Safety and Health Administration. Office of Regulatory Analysis SSTITOOOO AAA i i t ! C < 1 9 s U to o 0 TABLE II ANNUAL COST OF COMPLIANCE WITH LABORATORY STANDARD {$) Lab Type Chemical* Medical Hygiene Surveillance Plans Training Programs ' Hood Monitoring Recordkeeping Designated Personal & Maintenance Area Monitoring . TOTAL INDUSTRIAL Indep. Test Captive R&D 270,000 2,250,000 53,947 43,157 303,910 0 633.520 0 9,440 94,400 ' - r 23,377 199,755 151,050 1,658.625 i M93.949 4,197,232 CLINICAL Hospital Ind. Practice 0 383,040 / 61.283 65,599 ,o 0 0 1,348,134 29,491 20,086 71.497 54,666 405,620 275.278 ** 567,891 2,146,805 ACADEMIC Post Secondary Secondary Professional 364,500 100,800 161,280 20,715 241,681 1,656 750,542 1,281,034 0 1,710,507 1,419,096 0 10,195 24,761 2,115 . 20,140 11,313 : 21,966 219,478 51,150 207.467 . 3.100,698 3.116.016 403,902 TOTAL X of total 3,529,620 23. 5X 4B8.238 3.2X 2,335,486 . 5,111,257 15.5% . 34,OX 177,042 1.2% 367,477 3,017,373 15.026,493 2.4% 20. IX 100.OX Source: Boor, Allen A Hamilton; U.S. Department of Labor, OSHA, Office of Regulatory Analysis BILLING CODE 4S10-2S-C /Federal Register Vol. 55, No. 21 / Wednesday, January 31.1990 / Rules and Regulations 3308 Federal Register / Vol. 55. No, 21 / Wednesday. January 31. 1990 / Rules and Regulations 3309 OSHA estimates that the total addition, other benefits may be realized Chemicals in Laboratories'' has been annualized costs wduld'be $23.1 million since improved work practices may changed from "Occupational Exposures under the current General Industry prevent accidents-or other incidents not to Toxic Substances" as in the proposal. Standards compared to $15.0 million for directly attributable to a chemical The reason for this change, discussed in the Laboratory Standard. Such costs source. - ` greater detail later in this preamble, would not adversely affect the competitive status of the entities in any Technological Feasibility ~ resulted from the persuasive comments which called for consistency, to the of the laboratory categories. OSHA has determined that the extent possible, between the final Summary ofBenefits Laboratory Standard is technologically feasible. Its primary emphasis is on laboratory standard and OSHA's Hazard Communication Standard The new standard differs from many administrative controls necessary to (HCS). Thus, the term hazardous OSHA health standards in that it does protect workers from overexposure to chemical as used in HCS, and as it not establish new exposure limits, but hazardous substances in laboratories. relates to the definition of health hazard, sets other performance provisions Engineering controls such as fume has been included in this final standard. designed to protect laboratory workers from potential hazards in their work environment By permitting a greater . degree of flexibility to laboratories in developing and implementing employee safety and health programs. OSHA expects benefits to result from increased worker awareness of potential risks, improved work practices, appropriate use of existing personal protective equipment and greater use of engineering controls. Given the flexibility to design and implement innovative measures to reduce employee exposure to hazardous substances, . employers also will reap rewards in terms of lower insurance premiums, lower property damage costs, lower turnover costs, less absenteeism and. in general, increased productivity. Finally, the potential decrease in acute and chronic health problems wiil result in ~overall benefits to society through the associated reduction in medical and productivity costs. A substantial amount of evidence in this record Indicates that laboratory workers are at risk to serious and even life threatening occupational hazards. . ' . . hoods, vacuum systems and glove boxes, which are necessary to limit : chemical exposures, are considered conventional technology in this industry. This technology is commonly known and currently can be found in nearly all laboratories. -;-r . Regulatory FlexibilityAssessment OSHA has attempted to evaluate the expected cost of compliance for small entities. However, since a majority of labs are captive of larger establishments and firms, it was not possible to determine the precise impact on all - small entities. For those laboratories which are part of for-profit enterprises, the cost of the standard is estimated to . be less than 0.03 percent of annual revenues. - - - - The relatively small compliance cost3 associated with this standard are not expected to alter small firms investment plans, or be especially burdensome to small firms. Indeed, small firms will gain substantial cost savings as a result of the new exemption from general industry standards. In the preamble to the proposed standard, OSHA proposed to exempt _ certain laboratories (dental, veterinary - and group medical practices} from coverage by the standard. The final : standard does not provide for categorical exemption, but instead requires that determination of whether the laboratory standard applies be made on the basis of the definition of "laboratory scale" and "laboratory use." Under the proposal, the laboratory standard would have superseded all ' substance specific health standards with the exception of the permissible - exposure limits in subpart Z. There are. . however, instances where the final ' laboratory standard will not preempt the ' ' substance specific standard in any case. For example, the use of formaldehyde in histology, pathology and anatomy laboratories will remain under the Formaldehyde Standard (29 CFR 1910.1048} as directed by that standard. All other laboratory uses of formaldehyde will be covered by this final standard. As in the proposed standard, the final Several companies with good work Environmental Impact Assessment standard requires employers to develop practice programs, however, indicated As required by the National and implement a Chemical Hygiene Plan that these hazards can be overcome Environmental Policy Act (NEPA) of {CHP}. The CHP sets forth work through sound safety practices, and 1969 [42 U.S.C. 4321 et seq.), OSHA has practices and procedures to protect submitted evidence of the magnitude of reviewed the new standard and has - employees from health hazards in that the benefits to be attained from this determined that there will be no particular workplace. The final standard standard [Ex. 3-10, Ex. 3-24. Ex. 3-197. significant environmental impacts as a responds to the recognized need for Ex. 42]. These companies reported result of the action. The standard consistency in terms used in OSHA accident rates 30 to 80 percent below the focuses on reducing worker risk by standards and further clarifies when a industry average. OSHA estimates that means of work practices and procedures CHP must be implemented. ' the benefits resulting from this standard and therefore is not anticipated to . The proposed standard required include reductions in non-iost workday adversely affect ambient air quality, . employers to include in the CHP, special cases, lost workday cases, chronic water quality, solid waste, or land or measures for handling carcinogens. disabling illinesses. and chemical source vvorkplace cancers. It is projected that implementation of the standards will result in at least a 10 percent reduction in chemical-related illnesses and energy use. V. Summary of Major Differences - Between the Proposed and Final Standard This final rule, however, modifies the carcinogen definition and the obligatory action so that special provisions must be explicitly considered by the employer, but need only be implemented when the injuries in laboratories. Although precise Certain provisions have been employer deems them appropriate on estimates of current chemically related modified in the final standard to reflect the basis of the specific conditions injury and illness rates in laboratories comments submitted in response to the existing in his/her laboratory. Moreover, are not available, OSHA estimates that proposed standard. The following the term, "carcinogen" has been the Laboratory Standard will prevent -1 discussion summarizes the major replaced by "select carcinogen" which 235 of these non-lost workday cases, 82 : changes. covers a narrower range of substances lost workday cases. 60 chronic disabling The title of the final standard, ; (see discussion below, paragraph (b) of illnesses, and 40 cancers annually. In "Occupational Exposures to Hazardous this preamble). In addition, because it WV 000011157 3310 Federal Register / Vol. 55, No. 21 / Wednesday, January 31, 1990 / Rules and Regulations was pointed out in the record that other recommendations related to certain substances such as reproductive toxics aspects of the proposed standard. Most and acutely toxic chemicals also pose of these issues were related to specific severe hazards, the final standard also provisions and are detailed in the requires that the same special - paragraph-by-paragraph explanation of provisions as for select carcinogens be the final standard presented below. considered by the employer in the The comments, however, raised other Chemical Hygiene Plan. issues that also warrant further The proposed standard required that discussion and explanation. One such carcinogens be handled in a regulated issue is the perception that the proposed area. The final standard provides for the standard was duplicative in certain handling of select carcinogens where respects to OSHA's Hazard appropriate in a "designated" area, a Communication Standard. See. for term which is less restrictive and more appropriate for laboratory operations than the regulated area as defined in other OSHA standards. , ' Training and information provisions of OSHA's Hazard Communication Standard have been incorporated in the final rule so as to include physical hazards in the employer's training program as well as provide explicit training on health hazards involved. The medical coverage afforded employees by the final standard has been revised in accord with substantial comment received. Medical attention is provided by this standard under the following circumstances: (1) Whenever an employee develops signs or symptoms associated with exposure to a hazardous chemical; (2) in the event of an occurrence such as a leak, spill or explosion resulting in the likelihood of a 'gnificant exposure; or (3) whenever an action level (or in the absence of an example. Exs. 8-52, 8-85, 8-68, and 8114. In considering the two standards, it is important to note the objectives of each. The Hazard Communication Standard is designed to ensure that employees are apprised of the hazards associated with chemicals in their workplace so that they may make informed judgments regarding the necessary precautions to protect themselves. The*fmal laboratory' standard, on the other hand, requires that employers develop a comprehensive plan to implement those practices that safety and health experts have accepted as effective in minimizing laboratory employee exposures to hazardous chemicals. These practices, if followed, obviate the need to comply with the specific provisions of OSHA's health standards except in certain instances. See the discussion of scope and application (paragraph a). ' action level, the PEL) for an OSHA Paragraph (a). Scope and Application regulated substance for which there are exposure monitoring or medical surveillance requirements is routinely Preemption by Other OSHA Health Standards exceeded. In this case the medical As in the proposal, the final rule provisions of the standard must be provides that any substance specific complied with until the exposures are standard can require coverage to remain reduced below the action leveL under that standard rather than under In addition, when there is reason to . the laboratory standard. The preemption believe that an action level is routinely -1. issue was raised in the rulemaking exceeded, monitoring must be utilized to - proceedings for benzene and determine if that is the case. formaldehyde as well as in comments to VI. Summary of Issues and Explanation of Provisions of the Final Standard The rulemaking record on which this final standard is based overwhelmingly supports the approach taken by the Agency in its proposed standard (51FR 26660) to control occupational exposures to toxic substances in laboratories. Of the 129 written comments submitted in the proposed laboratory standard. Dr. Emmett Barkley of the National Institutes of Health stated: Clarification is required as to whether the laboratory standard should preempt a substance specific standard if the chemical in question is used is an ancillary process, and not directly a part of the research protocol itself (e.g. a test substance, reagent, intermediate product, etc.), even if the use of response to the proposal, 57 addressed this material meets ail of the criteria set forth the need for a separate standard for in the definition of "laboratory use of toxic laboratories. Approximately 91% (52) of substances". (Ex. 8-58). these 57 comments supported the need for the standard and agreed with OSHA's approach. (See, for example, _ Exs. 8-1. 8-14, 8-19, 8-23,8-25,8-32.840. 8-84, and 8-74.) General acceptance of the concept notwithstanding, there NIOSH further stated: It is important to very clearly state in the final standard that compliance with this standard does not alleviate compliance with more specific standards promulgated by OSHA (e.g. ethylene oxide and its use for . ere objections, concerns and non-research purposes) (Ex. 8-23). It has always been OSHA's intention that in the absence of a statement of preemption in a substance specific standard, the determination of whether the laboratory standard applies must be dependent on both "laboratory use" and "laboratory scale" criteria. Therefore, if these criteria are met, then this laboratory standard applies. The NIOSH comment specifically addressed ethylene oxide which is widely used as a steriiant. Since the ethylene oxide standard (29 CFR 1910.1047) did not expressly preclude its preemption by the laboratory standard, and even though used as a steriiant and not part of an experiment, the use of ethylene oxide in a laboratory will be covered by this standard, provided the use conforms to the "laboratory scale" and "laboratory use" definitions. OSHA believes that adequate protection is provided by this standard in the case of ethylene oxide. In the preamble to the benzene standard (29 CFR 1910.1028). OSHA discussed whether users of benzene in laboratories would be required to * comply with the benzene standard or ' the laboratory standard (52 FR 34528). OSHA stated that it would give additional consideration to this issue in the context of the laboratory standard rulemaking. Three commenters to the proposed laboratory standard felt that the benzene standard should not be preempted by the laboratory standard. Air Products and Chemicals Inc. (Ex. 8- 18) stated that. "When and if specific requirements regarding benzene are adopted for workplace exposure they should be added to an appropriate section of 1910 and not be buried in 1910.1450." Exxon Company (Ex. 0-35) agreed, saying. "If exposure is such that it meets the criteria of the benzene standard, then those workers would be covered by the benzene standard." Miles Laboratories (Ex. 8-091), too. regarded coverage under the benzene standard to be most appropriate, stating. "Medical surveillance for specific chemicals of increased risk should probably be handled through the General Industry Standards." Several others disagreed (Exs. 8-19, 8-36. 8-65, 8-66,8-107, 8-112, and 10-1), maintaining that no single substance should have special provisions. OSHA believes that under this final rule it has satisfied the real concerns of both sets of commenters. Under the laboratory standard, routine exposure above an action level will require the same exposure monitoring and medical surveillance provisions as in the relevant substance specific .standard, in this case benzene. VVV 000011158 Federal Register / VoL 55, No. 21 / Wednesday, January 31. 1990 / Rules and Regulations 3311 Therefore, by preempting the benzene rather than on the word "laboratory" stated that most detailed work is sent standard, this laboratory standard is itself. It was felt that it would be out to the larger diagnostic laboratories. providing more appropriate coverage for impossible to consider and categorize Nevertheless. Dr. Emmett Barkley (Tr. laboratories while continuing to provide every establishment, or even every type 118) testified that, in NIH veterinary full protection consistent with employee of establishment, that regarded itself as laboratories, chemical solvents, health and safety. a laboratory without clarifying criteria, anesthetic gases and medications and When the formaldehyde standard [29 and that a suitable course was to drugs which represent toxic hazards to CFR 1910.1048} was promulgated in December. 1987, it stated [52 FR at 46246) that formaldehyde use in histology, pathology and human or animal anatomy laboratories will continue to be covered by the establish coverage in terms of the "laboratory scale'' and "laboratory U3e" definitions to determine on the basis of a facility's specific activities and circumstances of exposure whether it was more appropriate to require employees are all used. It Is apparent to OSHA that the term, "veterinary laboratory" includes a wide range of different scales of operations and that this variation must be recognized in determining where this standard formaldehyde standard rather than the compliance with the provisions of this applies, laboratory standard. The preamble laboratory standard or the provisions of Mr. Norman Steere of Norman V. further notes (52 FR at 46246) that standards covering the specific Steere Associates, and Dr. Alan Todd of . formaldehyde exposures in other types substances involved. That is to say, Stewart-Todd Associates, Inc. (Tr. 141- of laboratories will be considered in the each facility would be judged on . 142] pointed out that a similar situation rulemaking for the laboratory standard. whether it met the criteria for the exists in medical laboratories, with No comments were received in the definitions of "laboratory scale" and potential exposure conditions varying record of the proposed laboratory "laboratory use." However, in preparing . significantly between various size group standard regarding the specific coverage the proposal, it was necessary to practices, large diagnostic laboratories ' of formaldehyde. In the absence of any - identify categories of laboratories for. and hospital laboratories. It therefore comments, OSHA sees no reason why purposes of analysis. Among the seems clear that grouping all such laboratories, other than histology. - - categories considered were veterinary facilities under one designation would pathology and anatomy laboratories, and dental laboratories and those . be inappropriate and that blanket ~ which use formaldehyde should not be associated with group medical practices. exemptions for such designations, as covered by this laboratory standard. OSHA believes that, with this laboratory standard in place, future rulemakings covering specific substances will have criteria by which to decide whether laboratories will more appropriately be covered by the standard being promulgated or the laboratory standard. It is not OSHA's intention to add requirements which do nothing to protect the health of workers. In order to further clarify the application of this standard. OSHA has added a OSHA proposed to exempt these facilities from coverage under the laboratory standard based on information then available (see 51 FR at 26672). In addition to comments received pertaining to the proposed exemptions. comment was also received regarding, in particular, whether or not facilities such ; as quality control laboratories and certain pilot plants should be covered by this standard. Exemption of any laboratories was proposed by OSHA. are consequently also inappropriate. Considerable comment was also devoted to whether "pilot plant laboratories" and "quality control laboratories" should be covered by this standard or by other General Industry standards. (Exs. 8-23. 8-24, 8-25. 8-41, 8-44, 8-45, 3-48, 8-69. 8-73. 8-79. 8-92. 893. 8-96. 8-100, 8-107, 8-110,10-6, Tr. 95-96. Tr. 253. Tr. 417-420, Tr. 435 and Tr. 440). Arguments were presented for new paragraph (a)(3) concerning scope and application. Paragraph (a)(3) states that this standard will not apply where opposed by Dr. Daniel Teitelbaum of the Denver Clinic (Tr. 45). Dr. Jay Young, chemical consultant (Tr. 72-73). Dr. VV. both positions. However, once again, great variation exists from one to another such facility. It is important to the only laboratory use of a hazardous Emmett Barkley of the National remember that one of the reesons for chemical provides no potential for employee exposure. Institutes of Health (Tr. 114), Mr. Frank this standard is to eliminate Grimes of the United Steel Workers (Tr. inappropriate requirements such as 284) and Dr. Gerald Hoeltge of the monitoring in workplaces which are Facilities American Society of Clinical characterized by conditions where very At the time OSHA began work on this standard a major problem was that of trying to define a laboratory. There are Pathologists/College of American Pathologists (Ex. 43). The basic position of all these commenters was that the small quantities of frequently changing substances are used. But where the quantities are not small and where the many facilities which are referred to as '`laboratories'* but which clearly should degree of protection afforded to an employee should not depend upon an substance in question is usually present, it is entirely appropriate to monitor and., remain covered by other OSHA arbitrary classification of the particular in such cases, employee health and standards and not by this one. It is laboratory. OSHA agrees with this safety is better served by complying important to consider the genesis of this argument in principle, but other with the requirements of the appropriate rulemaking to clarify this issue. As the comments brought out that there are OSHA substance specific standard. background discussion in section IV other relevant factors. Marcia Brody The record amplifies the inherent points out. the purpose of promulgating representing the American Veterinary difficulties in attempting to classify a laboratory standard was to provide a Medical Association (Ex. 41) pointed out facilities on the basis of what label is standard appropriate for situations in that veterinary "laboratories" were not placed on a particular "laboratory", i.e. which small quantities of multiple really laboratories in the intended sense "quality control", "group medical chemicals would be used--each, for the of this standard--that only minute practice", "pilot plant," for example. most part, for a relatively brief time quantities of substances in commercially Therefore. OSHA believes that duration. In trying to address this prepared kits are used and that, in most judgments about specific categories situation in the proposal, OSHA cases, no chemical reagents were used cannot be made on the basis of the label developed definitions for "laboratory at all. Supporting these comments were placed on that category and that scale" and "laboratory use" so as to those of Dr. Cleveland Brown, a categorical exemptions as were made in focus on the conditions of the workplace practicing veterinarian (Tr. 270) who the proposal are not appropriate. VVV 000011X59 3313 Federal Register / Vol. 55. No. 21 / Wednesday. January 31. 1S90 / Rules and Regulations . In general, pilot plant operations are typically closely connected with *" production processes. Such operations would fall outside the scope of the standard because they fail to meet the "laboratory use" definition which precludes laboratory procedures that. are part of a production process or in any way simulate a production process. However, the rulemaking record suggests that, in some cases, pilot plant operations are an integral part of a research function (see Tr. 453-454}. For example, as pointed out by Mr. Ron Larson of Exxon Research and Engineering Company, the pilot unit may consist of several small bench operations which are combined for the purpose of evaluating a particular effect. The operations do not always proceed to production but may remain part of the research activity. In these instances, if the pilot plant operation meets all other criteria for laboratory use and laboratory scale, it would indeed be within the scope of the standard. Therefore, although most pilot plants would not likely meet the required criteria for coverage under the Laboratory Standard, there are some which do and thus a blanket exemption for pilot plants is inappropriate. Similarly, most quality control laboratories are not expected to meet *he qualification for coverage under the aboratory Standard. Quality control laboratories are usually adjuncts of production operations which typically perform repetitive procedures for the purpose of assuring reliability of a product or a process. However, as with pilot plants, there will be exceptions, and where quality control laboratories meet the criteria of the definitions for "laboratory scale" and "laboratory use," they will be required to comply with thisstandard. It is OSHA's position that the determination, in general, of what facilities are covered must be made . specifically on the basis of the j definitions of "laboratory scale" and I "laboratory use". OSHA believes that these factors represent the appropriate criteria for describing the conditions and health hazards which make this regulatory action appropriate. Some commenters believed that these definitions should be amended so that their Facilities would be covered. (Exs. 8-20, 8-46, 8-69, 8-73, and 8-118). Others felt the definitions should be amended so they would not be covered. (Exs. 8--*2 and 8-44). These comments in themselves give testimony to the fact that the criteria . contained in the definitions are in most 'ses sufficiently clear to provide substantial guidance as to whether a facility is considered to be covered by this standard or whether it is covered by other health standards in subpart Z. An additional issue that was raised in the comments and hearing concerned the need to implement a Chemical Hygiene Plan when exposures are always minimal and involve substances which are of moderate or low toxicity. (See Exs. 8-79, 8-93,10-10 and Tr. 417418). OSHA believes that, in such cases, the standard is appropriate and reasonable because of the flexibility of the Chemical Hygiene Plan requirement Minimal exposures to chemicals of low toxicity will require a simpler Chemical Hygiene Plan because the standard, while requiring that specific considerations be addressed, leaves it to the employer to specify how. Therefore, the employer is able to address the required considerations in a manner appropriate to the substances and ' conditions in the specific laboratory. Chemicals ~ Reference was made in the proposed standard to the term "toxic substance" for the purpose of demonstrating when the Chemical Hygiene Plan, which *' outlined work practices and procedures to be taken to protect employees, was to be implemented. The term "toxic substance" was defined as any substance in 29 CFR part 1910, subpart Z as well aB substances determined to be carcinogens or potential carcinogens by IARC or NTP. However, once instituted, the work practices and procedures which the CHP specified were expected to be sufficient to provide protection from all toxic or hazardous substances regardless of whether they were included in the "floor" of toxic substances specified by the toxic substance definition. As noted in the preamble to the proposed standard, (see 51 FR 26671); (Tjhe impact of the standard is potentially broad since most laboratories would handle at least one substance which falls under one of the two categories and would therefore be required to implement work practices which would serve as effective protection against substances not explicitly covered by the standard but which may be potentially hazardous. In the final standard, the term "hazardous chemical'' is used in lieu of "toxic substance." The reason for this action is explained in greater detail later in this discussion. Early in the rulemaking activities for this standard. OSHA's information indicated some important factors to be considered in developing a standard for laboratories: (1) The implementation of carefully designed work practices and appropriate training are key to effective workers protection; (2) the diversity of laboratory operations would best be addressed by using a performance approach in which appropriate work practices and procedures are determined by the employer and (3) compliance with good laboratory practices, accepted by safety and health experts as effective, would obviate the need to comply with specific requirements prescribed in OSHA's substance specific health standards for * maintaining PELs. Accordingly, on the basis of this information. OSHA proposed that employers develop a Chemical Hygiene Plan as a mechanism to provide employee protection regarding substances regulated by OSHA as welt as other potentially hazardous * chemicals used in the laboratory. However, considering the number of comments which expressed an opinion regarding which substances the standard should address, it became obvious that the intended purpose of the Chemical Hygiene Plan, outlined in the proposal, was not clearly conveyed. Many commenters urged OSHA to expand the definition to include more substances, increasing employee protection from exposure to a greater number of harmful substances used in laboratories. Various suggestions were made on how OSHA should expand the scope of substances to be covered. Commenters (Exs. 8-15,8-20, 8-22, 8-25 and 8-97) specifically recommended that the toxic substance definition at least include the ACGIHILV list. For example, Kent R. Weber of J. T. Baker Chemical Company stated: The proposed rule uses OSHA PEL requirements to trigger the activation of this standard. Because the PEL'S can only be updated by a lengthy rulemaking process, * * ACGIH TLV's are a better and more upto-date list of standards. Use of ACGIH limits provides workers with the benefit of more current information and is more sensitive to the dynamic process of science as hazard investigations are carried out. As the preamble to the proposed rule indicates, only violations of the OSHA PEL standards would result in a citation, so use of ACGIH TLV's should not pose a regulatory burden on labs(Ex. 8-97). A similar view regarding the limitation of the proposed toxic substance definition was presented in the testimony of Dr. Alan Todd. Director. Industrial Hygiene for Stewart- Todd Associates, Inc. and expert OSHA witness: We concur with adding ***the professional, updated guidelines incorporated in the ACGIH TLV's ** *1 suggest that VVV OOOOl1X60 Federal Register / Vol 55, No. 21 / Wednesday, January 31. 1990 / Rules and Regulations 3313 Others, such as the AIHA. meaning the American Industrial Hygiene Association. Workplace Environmental Exposure Levels along with some of the NIOSH criteria, where there is no OSHA PEL, be incorporated by reference to supplement the PELS **' (Tr, 91). Other participants in the rulemaking proceedings suggested that the scope of substances covered by the laboratory standard should bq consistent with that of the Hazard Communication Standard ( 1910.1200). Testifying as an expert. 'OSHA witness. Dr. Jay A. Young, a -, chemical consultant, offered the . following recommendation: * The substitution of the term "hazardous chemical" as defined in the hazard communication standard for the term "toxic substance" as defined by the proposal will substantially increase the effectiveness of the proposed rule in preventing exposures to substances that are toxic but not now included in subpart 7 nor in the IARC or NIP carcinogen lists. There are only a few hundred chemicals that ere toxic included in subpart Z and the carcinogen lists; there are thousands of other chemicals that are toxic and that are also used in laboratories and which should be included in the purview of the proposed rule. A few of these taken at random ham a current laboratory supplier catalogue will illustrate my point. All of the following are toxic. None are included within the presently proposed rule Hazardous chemicals such as vanadates; selected bismuth compounds; acetyl halides and derivatives; hydroxylamine hydrochloride; selected indium compounds, perchloric acid and selected derivatives: phosphorous oxychloride: phosphorous (III) and (V) halides; sulfurous acid: suifuryl halides (in addition to the fluoride); selected tetramethyl ammonium derivatives To reduce the risk of harm in chemical laboratory work, chemicals such as the above should be included, just as they already are included under the hazard communication regulation (Tr. 70-71). Consistency between HCS and the final laboratory standard in terms of substances covered was also recommended by Dr. Frank R. Ciofalo on behalf of Cal/OSHA: The'term "toxic substances for laboratories" will get confused with "hazardous substances" for HCS as well as the specific definition of "toxic" and "highly toxic" in HCS. Therefore, the exact . terminology should be transported to the CHP." (Ex. 6-28). Similarly. David Chawes. Senior .Industrial Hygienist for the Ecova Corporation commented: The definition of toxic substances Proposed is at variance with the existing OSHA definition of toxic substances used in the Chemical Hazard Communication Standard. This variance is unacceptable, because many institutions and employers 'rith laboratories have already adopted the Hazard Communication definition To introduce a new definition of ''toxic" * * * would be counter-productive and would result in employee and employer confusion. (Ex. 8-34). Although the majority of participants supported the need to expand the scope of substances covered, there were, however, some commenters who opposed coverage beyond OSHA regulated substances. For example, the written submissions of Exxon Company U.S.A. (Ex. 8-35) and Monsanto (Ex, 8- . 36) shared the concern expressed by Hof&nan-LaRoche who stated. ; believe that coverage by this standard should be limited to substances for which there is an OSHA PEL. There are several difficulties in including the ACGIH TLV standards; it would give them a pseudoregulatory status: '"we strongly urge that before ACGIH TLVs are even suggested as "guidelines,'' they be published as proposed additions to OSHA's list of PELs with an opportunity for comment (Hoffcnann-La Roche Inc.. Ex. 8-111). In response to these latter comments. OSHA would like to reiterate the arguement it made in the preamble to the proposed standard regarding the appropriateness of including under the scope of the standard substances determined to be carcinogenic by IARC or NTP. As stated at (51 FR 26665): 1 OSHA determined in file Hazard Communication Standard that it was appropriate to require certain procedural provisions for substances for which OSHA had not set an exposure limit and that this type of provision was much lesser in scope than setting an exposure limit and that the appropriate legal analysis was the discussion by the Supreme Court of "backstop" provisions in Industrial Union Dept. v. American Petroleum Institute. {See the discussion at 48 FR 53296-9. 53321 and at 448 U.S. 697.658.) OSHA believes that this reasoning is equally appropriate (inclusion of substances for which there is no PEL] for the purposes and intent of this standard. This standard was designed expressly for laboratories to address the unique exposure conditions under which work is performed and to protect employees from adverse health effects that may result from their work in laboratories regardless of what toxic and hazardous . - substances are used. In contrast to those who argued that OSHA's authority with respect to the protection of laboratory workers should be restricted to OSHA regulated substances. OSHA believes that any standard of this nature which does not include consideration of all potentially hazardous chemicals would not be an appropriate solution to - providing the desired level of employee protection. This standard sets no exposure limits or threshold limit values. However, because substances.which are involved in laboratory use are acknowledged to produce adverse health effects which could result in significant risk, then certainly protective measures are appropriate. Supporting the concept of an all inclusive standard, the Chemical Manufacturers Association (CMA) suggested that a standard which applied only to PEL substances would be less protective than one which applied to a broad range of hazardous substances whether regulated or not. As George Stout, representing CMA. concluded in his testimony: The current PELs have little impact on the total exposure hazard of most laboratories. The overwhelming number of materials handled in laboratories have no PELs. Often, the toxicity information is scanty or non existent. A performance-oriented good laboratory practices approach helps reduce risk for both regulated and unregulated materials. (Tr. 251). OSHA agrees with the arguments submitted to the record which suggested that where feasible there should be consistency in its standards so as to eliminate confusion with respect to compliance and ensure the greatest measure of employee protection. Such is the case with the final laboratory standard. Laboratories in the manufacturing sector, as well as other laboratories as a result of the expansion of scope of the Hazard Communication Standard (52 FR 31852. August 24.1987), are covered by certain provisions of that standard. The term hazardous chemical, is used in the Hazard Communication Standard. To introduce a new term, "toxic substances," which lists fewer chemicals regarded as hazardous to laboratory workers could create confusion. (See. for example. Exs. 8-28 and 8-34). In view of the comments submitted and the recognized need for consistency, OSHA has decided to incorporate the term hazardous chemical into this final standard. However, the use of this definition makes no change in the intent evinced in the preamble to the proposed standard. It should be recognized that, while appearing to enlarge the impact of the standard, this action will actually create little additional burden to employers. The intent has always bt^n to mandate the implementation of an overall Chemical Hygiene Plan for the entire laboratory whenever any substance included in the scope cl the standard was present. Therefore, any substance regulated by OSHA would automatically trigger the program for the laboratory as a whole. Since very few VVV 000011161 3314 Federal Register / Vol. 55, No. 21 / Wednesday. January 31, 1990 / Rules and Regulations laboratories will be free of all regulated substances, most laboratories would need (o comply with this standard even if the scope were limited to such substances. The expansion of the scope to cover all "hazardous chemicals'' should add few workplaces to those which will need to comply anyway. The addition of the term hazardous chemical will further clarify the fact<that the laboratory employer must offer protection to all employees in all : laboratory work situations. know of several deaths that have occurred from laboratory-acquired infections, and from laboratory fires or explosions, so 1 conclude that to omit the physical and biological hazards may be omitting a major portion of the problem (Tr. 129). Dr. Alan Ducatman of MIT advised OSHA to complete the initiative that it had already begun and revise the standard to incorporate protective measures for other laboratory hazards at a later date. In response to a question regarding his position on whether OSHA should include biohazards under the Inclusion of Safety Hazards proposed laboratory standard. Dr. . In a related matter, OSHA requested Ducatman replied: comments and information on the I think it's so important that this proposal appropriateness of developing a vertical standard for laboratories, covering both safety and health hazards. Some commenters (Exs. 8-20, 8-38. 8-70, 8-74, 8-75, 8-78.8-108.10-12 Tr. 47, Tr. 129, Tr. 285, and Tr. 294} recommended that go through, that I would certainly be willing to see it go through without that But. I would like to see, eventually, biohazards wrapped in. If not immediately, eventually, and that is because as our institutions become more technical, biology and chemistry are merging. In fact, biology, chemistry, and physics are OSHA Include measures to protect merging. I think it is important that we try we laboratory workers from additional hazards such as biological, radiological and physical hazards such as fire and explosion. For example, the AFL-CIO get the most universal standard that we can. At this time. 1 don't think you have to do that. I think you should make it a future goal. (Tr. 183) stated: OSHA recognizes that laboratory * * * Chemicals which pose health hazards may also pose fire and explosion hazards. Health hazards are not limited to toxic chemicals, but include biological agents employees may be exposed to potential hazards that are not addressed by this standard. However, since the initial emphasis for a separate laboratory and physical agents like radiation. Any standard designed to protect laboratory workers should not make artificial distinctions between toxic chemicals and ether agents and between health hazards and safety hazards. Control measures should consider the laboratory environment as a whole and respond to all hazards present. ; The standard should be expanded to standard was directed toward the inappropriateness of OHSA'S health standards for laboratory work, the record Is not completely developed regarding other hazards facing laboratory personnel. While this standard exempts laboratories from most provisions of subpart Z, other [provide} comprehensive coverage of toxic subparts of 29 CFR1910 which address chemicals, biological and physical agents and physical hazards remain in effect for both health and safety hazards. (Ex. 8-75]. - laboratories. For example, laboratories Mr. Chain Robbins, manager of Health and other general industry employers and SaTety for International Technology must comply with subpart H which Laboratories, emphasized the oeed to pertains to hazardous materials and address physical hazards in this includes regulations for compressed standard. Mr. Robbins stated: gases and flammable and combustible * * * It has been the experience in International Technology Laboratories that physical hazards have been those which have caused the most significant worker injuries liquids and subpart C--Occupational Health and Environmental Control-- . which contains regulations for noise exposure and radiation. * * * We believe that any laboratory standard for worker protection must include requirements for employers to address the physical hazards identification and controls necessary to prevent losses. (Ex. 8-74). , Moreover, other comments indicated that OSHA's safety standards which cover physical hazards do not present the same type of compliance problems for laboratories as do its health Norman Steere, consultant on standards. Such views expressed by laboratory safely, also urged OSHA to Exs. 8-9, 8-18, 8-19, 8-36, 8-42 and 8-68 include biological and physical hazards ' were similar to the following comment under the standard. Mr. Steere stated: submitted by Eastman Kodak Company: * * I believe that the proposed standard should apply to all of the hazards encountered in laboratory workplaces, j?-; [pcludinn physical and biological hazards ' any Per*nally unaware of a. We believe the rule, as proposed, should be i:mited to regulations of occupational exposures to toxic substances in laboratories and should not extend to cover other general laboratory safety issues which are currently - addressed in other OSHA standards, such as flammability, corrosivity, and explosivity. Such hazards in laboratories are not significantly different from those in general industry, and attempts to incorporate protection against such hazards in this proposed rule would delay and complicate the development of appropriate Chemical Hygiene Plana, (8-118). OSHA believes .that the requirement for training on physical hazards, in conjunction with current safety regulations, should improve effective employee protection. Therefore, although the final laboratory standard does not dictate provisions for work practices to protect employees from potential physical hazards associated with chemicals used in their work areas, it does require that such physical hazards be addressed in the employer's training program. (See 29 CFR 1910.1450(f)(4)(B).) Currently, OSHA has no regulations which specifically address biological hazards. However, the Agency has issued a proposed rule entitled "Occupational Exposure to Bloodbome Pathogens" (54 FR 23042. May 30.1989). When the Agency promulgates a final standard on this subject, laboratory workers would be included under its coverage. Meanwhile, several guidelines are available which make recommendations pertaining to biosafety for laboratories. For example, the Centers for Disease Control and the National Institutes of Health have jointly published "Biosafety in Microbiological Laboratories." In addition, the National Committee for Clinical Laboratory Standards has recently issued a proposed guideline entitled "Protection of Laboratory Workers from Infectious Disease Transmitted by Blood and Tissue." Because of the aforementioned considerations, including the record evidence, OSHA believes that the fccus of this final standard is appropriate and addresses the most critical areas of need with respect to laboratory worker protection. Paragraph (b) Definitions The proposed standard contained definitions to facilitate interpretation of its provisions and intent Extensive explanation was provided in the preamble for those definitions which were unique to the proposed standard. In the final standard, certain definitions remain unchanged from the way they ' were proposed since there was little or no objection in the record regarding - their content or purpose. The following terms are defined identically in the proposed and final standard: "Assistant Secretary", , "Chemical Hygiene Officer", VVV 000011162 Federal Register / Vol. 55, No. 21 / Wednesday- January 31. 1990 / Rules and Regulations 3315 "emergency", "laboratory-type hood", and this final standard since and "protective laboratory' practices and laboratories are subject to both - equipment" The explanation for certain regulations. Therefore, in the final of these terms is repeated in this standard the Agency incorporates the discussion of definitions to assure that term hazardous chemical which is their original intent is clearly conveyed defined as any substance which meets in the final standard. the definition of health hazard under the The final standard retains the Hazard Communication Standard. proposed definition for "Chemical in a similar action. OSHA has Hygiene Officer." As defined, the substituted the term, "designated area" "Chemical Hygiene Officer" is an in the final standard for "regulated employee who is designated by the area" defined in the proposed standard. employer, and who is qualified by "Regulated area" is a term that is used training or experience, to provide in moat of OSHA's substance specific technical guidance in the development health standards. Typically, it refers to and implementation of the employer's . an actual demarcation that is Chemical Hygiene Plan. Use of this term established in the work area to minimize is not intended' to place any limitations and restrict the number of employees on the job title or position description exposed. Also, under the 13 carcinogen which the designated individual shall .standards, specific procedures such as hold within the employer's-organizatioo. showers and attendance lists were Consequently, the term "Chemical required for those working in regulated Hygiene Officer" may apply to another areas. Commenters objected to the - job title provided that the designated proposal's requirement that work with , employee is technically competent to carcinogens be performed in regulated fulfill die responsibilities of developing - areas, perhaps because of the the way and administering the employer's - the term had been used in other Chemical Hygiene Plan. standards (see e.g., 23 CFR 1910.1008 (cl, As in the proposed standard, the term (dK3Mf).fg). "laboratory" is broadly defined by The primary purpose of the intention in the final standard. The basis "designated area" is to focus attention for this standard focuses on the - on the-fact that a particularly hazardous conditions of chemical usage commonly substance is being used and to ensure, found in laboratories and not on the where appropriate, that appropriate * particular classification or category of protective measures are observed by laboratory operations. Although certain ' employees working in or near the categories of laboratories have been vicinity. The purpose is not to restrict mentioned for purposes of preparing the use oflarge areas oflabora lory cost estimates, the determination of space.-Since the term "regulated area'v which laboratories are covered by this has a more restrictive meaning in other standard will be based on whether or - OSHA standards, OSHA decided ft was not conditions of "laboratory use" and unnecessarily confusing to use the same "laboratory scale" as defined in the term in this standard to mean something standard exist in the particular less restrictive. Therefore. OSHA has workplace. decided to use the term "designated As a result of changes to the proposed . area" in the final standard in lieu of standard, certain proposed definitions "regulated area". "Designated area" were deleted in the final standard because they were no longer relevant "Closed system" and "exposure means an area which may be used for work with "select carcinogens." reproductive toxins or substances which evaluation", for example, are neither referenced in the final standard nor included in the final standard's have a high degree of acute toxicity. A designated area may be the entire laboratory, an area of a laboratory or a definitions. In some cases definitions have been substituted for the proposed terms and in other cases definitions have been device such as a laboratory hood. The proposed standard did not define employee. Recommendations that the term be defined were included in the added or amended for clarification. For - record, see for example. Exs. 8-32. 6-96 example, the term "hazardous chemical" and 8-104. The final standard defines substitutes for "toxic substance" defined to the proposed standard. The term hazardous chemical" used in this final J^le relies on the definition of "health hazard" found in the OSHA Hazard Communication Standard. As discussed to the scope and application section above, commenters urged OSHA to employee as an individual employed in a laboratory workplace who may be exposed to hazardous chemicals in the course of his or her assignments. Such individuals may actually work in the laboratory or because of their work assignments may be required to enter a laboratory where potential exposures toaintain consistency in terms between may occur. In the latter category. OSHA the Hazard Communication Standard considers maintenance and custodial personnel as meeting the definition of employee. The definition of employee would not include occasional visitors to the laboratory such as guests or sales personnel. The term, "carcinogen," as defined by the proposed standard has been replaced by the term "select carcinogen" in the final standard. The proposal defined a carcinogen as a substance regulated by OSHA as such or identified by IARC or NTP as a carcinogen or potential carcinogen. Under the proposal, laboratories working with carcinogens were required to implement more rigorous procedures under their CHP. including the use of fume hoods. Objections were raised to this blanket approach (see e.g., Exs 8-19. 8-107,10-9 and Tr. 112-113}. Many substances in this category could be regarded as weak carcinogens, particularly in the context of laboratory use. Therefore the final laboratory standard uses a modified term, "select carcinogens." in defining those chemicals for which additional carcinogen provisions, including the designated area provision, may-apply. As noted above, the final standard defines "select carcinogen" as any substance regulated as a carcinogen by OSHA. and known human carcinogens identified by IARC or NTP. Potential carcinogens listed by IARC and NTP are considered "select carcinogens" for purposes of this standard only if they meet the stated criteria for demonstrating moderate to high carcinogenic potency in animal studies. The definition of "Chemical Hygiene Plan" has been amended in a minor way to clarify that its purpose is twofold. It is a written plan which is to be developed and implemented by the employer that sets forth procedures, and other work practices which are capable of: ft) Protecting employees from the health hazards associated with hazardous chemicals in that workplace and (2) meets the requirements outlined in paragraph (e) of this section. Paragraph (e) specifies the elements to be addressed and instructs the employer to ensure that the CHP is capable of keeping employee exposure below designated PELs. The definition of "laboratory scale" is retained in the final standard. The purpose of this definition is to focus on the magnitude of the operations which are covered. OSHA rejected the option to specify quantity limits as criteria for "laboratory scale." realizing that any limit specified would be arbitrary. However, the concept of quantity is certainly relevant. Therefore, the most reasonable approach Is to define laboratory scale in relation to the size of yVV OOOOIH^3 3316 Federal Register / Vol. 55, No, 21 / Wednesday, January 31. 1990 / Rules and Regulations ' containers used in reactions, transfers and other operations and. in general terms, to the quantity of materials handled. The proposed definition of "laboratory scale" referred to work with substances in which the containers used for reactions, transfers and other - ' handling of substances are designed for manual use. being small enough to be easily and safely manipulated by one person. The final standard revises the definition slightly to eliminate the requirement that containers be manipulated manually. Several commenters (see Exs. 8-112 and 10-2) 1 pointed out that laboratory work frequently involves automated procedures. It was not OSHA's intention to exclude such operations from coverage. Other comments (Exs. 4-45, 850. and 8-64) suggested that the definition be amended to allow for non routine tasks such as assistance from co-workers in handling 5-gallon drums and gas cylinders used in laboratory operations. As pointed out in the ' preamble to the proposed standard at 51 FR at 26673, the intent of the definition is not to exclude the use of facilitative mechanical aids when needed (and similarly would not preclude the assistance of co-workers when necessary). OSHA believes that the definition of "laboratory scale," as revised, is broad enough to satisfy the 'concerns of these particular commenters without further revision. The definition, of "laboratory use of hazardous chemicals" modifies the proposed term "laboratory use of toxic substances" in a minor way. A new criterion has been added to read as follows: "The procedures involved are not part of a production process, nor in any way simulate a production process." For the sake of clarification, OSHA wishes to point out that criterion (d), "protective laboratory practices and equipment are available to minimize the potential for employee exposure to hazardous chemicals." is not intended to imply that such practices are implemented and such equipment are available in a particular laboratory. Rather the intent refers to the fact that a body of information, accepted by safety and health experts, is available . regarding the effectiveness of such practices and equipment in protecting laboratory workers. It was never OSHA's intention to exclude ' laboratories from coverage by the standard in the event these practices and equipment were not immediately available in a particular laboratory workplace. To the contrary, OSHA believes that any laboratory in which this criterion is not met currently dearly stands to benefit significantly from this standard. Benzene (52 FR 34563, September 11. 1987).) .. OSHA has concluded, on the basis of persuasive arguments in the record, (see, for example, Exs. 8-9,8-20. 8-74) that the final laboratory standard should include training on "physical hazards" consistent with the Hazard Communication Standard. Therefore, the definition of physical hazard as used in the Hazard Communication Standard as well as the definitions of associated . terms are incorporated in the final For purposes of this standard, permissible exposure limit refers to any established OSHA exposure limit whether it be a TWA, ceiling, STEL, or excursion. In addition, prohibition of eye and dermal contact where specified by an OSHA standard also remains in effect. Paragraph (d). Employee Exposure Determination laboratory standard. The final standard also includes a definition for "reproductive toxins." since employers will be required to include additional protective measures in the Chemical Hygiene Plan where appropriate for work involving such substances. The final standard defines "reproductive toxins" the same way as the Hazard Communication Standard. While most agreed with the concept of requiring laboratory compliance with existing PELs, two commenters pointed out that the lack of monitoring and medical examination requirements left open the possibility that an employee could be exposed to levels greater than permitted by an OSHA limit for a substance and have less protection than an employee in a workplace covered by Paragraph (c). Permissible Exposure the relevant substance specific Limits standard. Margaret Seminario of the The final standard retains the AFL-CIO stated that: requirement that laboratories comply The standard should require that initial . with the permissible exposure limit environmental monitoring be conducted for (PELs) in effect for general industry. The Agency determined that such action was necessary to ensure that there would be no diminution in the health protection of chemicals and agents which are used on a regular basis (i.e. more than 30 days a year). If exposures are more than one half the permissible exposure limit, semi-annual monitoring should be conducted until 2 laboratory workers. ........ consecutive sets of measurements show OSHA has reviewed the complete ... exposures below the action level. This is record established for this rulemaking ... . flimilar.to the monitoring requirements under and has found no opposition to retaining . other OSHA health standards. Laboratory compliance -with the existing PELs. workers who are exposed to chemicals and However, the comment submitted by agents on a regular basis should be afforded Public Citizen (Ex. 8-70J made OSHA the same degree of protection. (Ex. 8-75). aware of a need to clarify what constitutes a permissible exposure limit for purposes of this standard. Public' Citizen pointed out that OSHA proposed to retain permissible exposure limits (described as measurement of an 8-hour time weighted average) but did not mention the short-term exposure limit (STEL) in effect for some OSHA regulated substances. The comment Dr. Daniel Teitelbaum of the Denver Clinic Medical Center also pointed out the need for consideration of action levels in addition to exposure limits: In this standard, air monitoring is not required because of the-highly variable .nature of exposures which might occur in the laboratory. For many substances, usage will be brief and transient and these materials must be used in hoods or with other gear correctly indicated that short-term exposures may be more dangerous than an equivalent dose occurring over a longer period of time. Reference to permissible exposure limits does not cover 8-hour time- w'eighted averages (TWAs) only. The air contaminants standard (29 CFR ' 1910.1000), for example, designates ceiling values, acceptable ceiling which should protect the users. For some substances like lead and arsenic, however, exposures even below the PEL may cause physiological changes which indicate early toxicity. For those materials for which a specific definition of exposure at some level below the PEL such as the action level for lead. haB been included in another standard, that definition of exposure should be the applicable definition when these chemicais concentrations as well as 8-hour timeweighted averages for various substances. Certain substance specific standards include both 8-hour TWAs and STELs under the term permissible exposure limit. (For example, see are used in the analytical work of the laboratory. Such provisions should apply particularly to lead, arsenic, asbestos, acrylonitrile, and many other materials for which there is good data on adverse, but subclinical, effects of low exposure. (Tr. 38-39). Occupational Exposure to In reviewing the issues raised in these Formaldehyde (52 FR 46292, December 4. comments, OSHA considered several 1967), and Occupational Exposure to points. First, in establishing a standard vvv ooooiu*^ Federal Register / Vol. 55, No. 21 / Wednesday, January 31, 1990 / Rules and Regulations 3317 particularly appropriate to-laboratoriesl it was never OSHA's intention to ailow a lesser degree of protection fof . laboratory employees than for other employees. Second, this standard is based on the premise that laboratories should be accorded special treatment partly because quantities of particular substances are small and the substances themselves are frequently changing. If these conditions did not occur there would be no need for a separate laboratory standard and the workplace should remain subject to the other DSHA General Industry standards as required. Therefore. OSHA concurs with the comments from Ms. Seminario and Dr. Teitelbaum. Since minimal exposures are a premise of this standard. OSHA considers it appropriate that, where exposures are routinely above the action level (or in the absence of an action level, the PEL} for an OSHA regulated substance for which there are exposure monitoring or medical surveillance requirements, the employer shall comply with those exposure monitoring and medical surveillance requirements. By use of (he word "routinely," OSHA intends to convey a condition which would be similar to an industrial setting where the ambient concentration of a substance is at a characteristic level as a result of the workplace conditions and the particular process involved. Factors which might raise the possibility of overexposure include the following: (1) The manner in which the chemical procedures or operations involving the particular substance are conducted [e.g. use of open vessel Instead of a closed system); (2) the existence of historical monitoring data which shows elevated exposures to the particular substance for similar operations; (3} the use of a procedure which involves significant quantities or is performed over an extended period of time; or (4j signs or symptoms of exposure (e.g. skin and eye irritation, shortness of breath, nausea, headache, efc.) which are experienced by the employee. The final standard requires that if, based on conditions such as those cited above, there is reason to believe that a tegulated exposure level related to a standard which contains exposure Monitoring and medicalsurveiilance " fequirements is present in excess of the action level (or in the absence of an . aotion level, the PEL), then the employer. hiust conduct employee exposure .... Monitoring for the substance in question. I* it is found that the action level or PEL ' k routinely exceeded, then the employer Must comply with the monitoring and medical provisions of the relevant standard until the exposure level is brought to or below that prescribed by. the particular standard or until the substance is no longer used in the same procedure. II the exposure monitoring discloses a level below the action level (or PEL where no action level exists), then no further monitoring is required and the employer continues to comply only with this laboratory standard. However, it should be noted that termination of monitoring as prescribed by the relevant standard for a particular overexposure episode does not preclude future monitoring in accordance with the requirements in paragraph (d)(1) foe recurring exposure to that particular substance. Since, as stated earlier in the discussion of this paragraph, this standard is justified on the basis of limited exposures, this provision will impose no burden at all on most employers, and where exposures are high, it will place no unreasonable burden on employers. Paragraph (e) Chemical Hygiene Plan The final standard retains the provisions for a written Chemical Hygiene Plan (CHP) that is to be formulated and implemented by the _ employer. The CHP must outline specific work practices and procedures which are necessary to ensure that employers are protected from health hazards associated with hazardous,chemicals with which they work. The Chemical Hygiene Plan concept was generally supported In submissions to the record (see e.g. Exs. 8-10. 8-20, 8- 27,8-73,8-97, 8-108 and 10-16). The importance of such plans in providing employee protection was indicated by the Procter and Gamble Company: Written safe work practices are often the most important component of a good safety program, especially when they are used as the basis for periodic education and training of employees. The written Chemical Hygiene Plans (CHP) required in the proposal are . . appropriate for laboratory uses of toxic substances. Consistent with the performance orientation, the final standard should list the elements to be addressed in the CHP, while allowing maximum flexibility for employers to develop the appropriate CHP's for their laboratory operations. (Ex. 8-73). A question asked during the course of this rulemaking was whether a CHP would be required for each individual laboratory in establishments with many separate laboratory operations or whether a single, facility-specific plan would suffice. Considering the performance orientation of this standard and the diversity in laboratory . operations, OSHA believes that this question should be decided locally by the facilities covered. Ideally, the plan should be specific enough to a particular workplace that it does not require employees to familiarize themselves with extraneous material that is not relevant. However, it is not the intention of this standard to dictate the approach that the employer may find effective in meeting the objectives of the CHP or the manner in which it is implemented. The final standard, like the proposal, specifies certain elements that must be addressed by the CHP but generally leaves the particular details to the employer's discretion. Non-mandatory guidance on the development of an acceptable and effective Chemical Hygiene Plan is provided in Appendix A. The term "hazardous chemical" (replacing toxic substance as defined in the proposed standard) is defined for the purpose of demonstrating when the CHP is to be implemented. Thus, if any chemical meeting the definition of "hazardous chemical" as it relates to health hazards is used by the laboratory, the CHP is to be implemented for the laboratory in general and must automatically cover any hazardous chemical present. The employer's Chemical Hygiene Plan must be readily available to employees, employee representatives and. upon request, to the Assistant Secretary or designee. The employer must review the CHP at least annually and update it as necessary. The Plan must include several spedtic elements which are deemed necessary to ensure laboratory employee protection. Although specific elements are required, they are general enough to allow a performance approach. Furthermore, in view of the fact that most laboratory employers already have health and safety programs which include some or most of these elements the specification does not impose a significant regulatory burden on employers. The employer's Chemical Hygiene Plan must incorporate standard operating procedures (SOFsJ which are appropriate for the particular laboratory workplace for all work involving hazardous substances. Only a few comments in the public recored addressed standard operating procedures. Three commenters (Exs. 820, 8-106 and 10-16) supported the provision aa essential in performing work with toxic and hazardous substances. Other commenters (see Exs. 8-84, 6-95 and 8-114] suggested that the provision was loo restrictive, particularly for research settings. VVV 00001U65 3318 Federal Register / Vol. 53, No. 21 / Wednesday, January 31, 1990 / Rules and Regulations However, further examination of these particular comments underscored what OSHA believes was a lack of understanding of the intended purpose of the provision. OSHA did not specify the contents to be covered under the SOP'S, as they would vary with each facility and would best be determined by the employer.. The purpose of SOP's is to assure that work practices and policies that the employer may deem necessary to protect employees from chemical hazards in the laboratory are in place. SOP's, for example, may specify general safety precautions (e.g. safety glasses, eating and drinking area restrictions, general housekeeping practices) accident response, disposal procedures and spill clean-up procedures. The employer must also include in the plan criteria which would invoke the use of specific exposure control measures. Such criteria may be based on thedegree of toxicity of the substances to be used, the exposure potential of the chemical procedures to be performed and the capacity of the engineering controls, administrative practices or protective equipment to control employee exposures effectively. . Additional requirements must be included in the CHP where appropriate to protect employees working with particularly hazardous chemicals such as select carcinogens, reproductive toxins and chemicals exhibiting a high degree of acute toxicity. The final standard also requires that employers incorporate in their Chemical Hygiene Plan measures to assure the proper functioning of fume hoods and other protective equipment. As in the proposed standard, the final standard does not specify face velocities for fume hoods. OSHA's rationale for this ' approach was explained in the preamble to the proposed standard (see 51 FR at 26671). In brief, the preamble stated that OSHA recognized that there was considerable debate over what optimum velocities should be in light of differences in hood design and methods of operation. Moreover, it was felt that requiring specific face velocities was not consistent with the performance orientation of the standard. Most commenters agreed with OSHA's approach in not specifying face velocities for fume hoods. For example, the Aluminum Company of America stated: . OSHA asked whether the Standard should specify face velocities for lab hoods. We feel it should not include a specification because ventilation needs vary with the specific design and use of lab hood. Nevertheless, adequate and continuing performance of lab hoods is critical to employee health protection and we support the requirement that the Chemical Hygiene Plan address the proper use and functioning of laboratory hoods. (Ex. 8-16). Other commenters sharing this view included Exs. 8-18, 8-19. 8-20.8-36. 8- 42, 8-48. 8-58. 8-65. 8-79, 8-91, 8-107, 8- 111 and Tr. 137-139. There are some comments in the record which suggest a need for OSHA to specify face velocities for fume hoods in the final rule. (See e.g. Exs. 8-66, 8-96, 8-108 and 10-14). However, these comments offered little or no substantive information to persuade OSHA to abandon the performance approach which allows the employer to determine the appropriate face velocities on the basis of design, use patterns and other factors which influence the effectiveness and proper functioning of the fume hood. In addition, the employer's Chemical Hygiene Plan must identify those procedures, activities or operations which the employer believes to be of a sufficiently hazardous nature to warrant prior approval from the employer or the employer's designee before implementation. - The CHP required by the final standard retains many of the elements of the proposed standard Certain revisions have been made, however, in_ response to comments and evidence in the record. In particular, OSHA has altered its position regarding the handling of carcinogens under this final standard. Under the proposed standard employers were required to include in the CHP additional protective measures for work with carcinogens. A carcinogen was defined as a substance that met one of the following criteria: (1) Is regulated by OSHA as a carcinogen or (2) is identified by the International Agency for Research on Cancer (IARC) or the National Toxicology Program (NTP) as a carcinogen or potential carcinogen. (See 51 FR at 26678). The additional protective measures that were to be taken when handling these substances included: (l) Establishing a regulated area, defined as a laboratory, an area of a laboratory or a device such as a laboratory hood for which access is limited to persons who are aware of the hazards of the substances in use and the precautions that are necessary; (2) requiring that all work be conducted in a fume hood or equivalent containment device; (3) specifying procedures for the protection of vacuum lines and pumps from contamination and the safe removal of contaminated wastes: and (4) specifying personal hygiene practices and appropriate protective apparel for work in a regulated area. Numerous comments were submitted on the approach taken in the proposed standard with respect to carcinogens and the relationship of carcinogens to other highly toxic substances which give rise to both chronic and acute effects. Regarding the proposed standard's overall approach to carcinogens, specific issues were raised that included: (1) The carcinogen definition; (2) the application of identical requirements for all substances identified as carcinogens without regard to potency, concentration, physical properties or use conditions; and (3) the rationale for requiring special provisions for work with carcinogens while allowing employers to determine appropriate employee protection for work with other substances considered to be equally hazardous. The proposed carcinogen provisions proved to be controversial. In several cases (see Exs. 8-12, 8-59, 8-95, 8-96, 8118, and 10-9) commenters recommended that the definition be restricted to OSHA regulated carcinogens, suggesting that otherwise more stringent precautions would be imposed on laboratories than on other industries using the same materials. These comments also objected to the -inclusion of substances listed by IARC and NTP since such substances had not been subjected to the regulatory review process. With respect to these particular concerns, it is important to remember the premise upon which the proposed standard was based, i.e., the need for special considerations for the laboratoiy use of toxic and hazardous substances regardless of their regulatory status. A significant number of commenters (see Exs. a-19. 8-20. 8-26. 8-30, 8-37, B41, 8-52, 8-68, 8-66. 8-69, 8-84, 8-93 and 10-5] expressed concerns that the carcinogen definition and associated provisions did not consider the wide variation in carcinogenic potency nor make allowances for such factors as concentration, quantity, physical properties or conditions surrounding the substances' use. The following excerpts are examples of comments addressing these particular concerns: The California Institute of Technology, (Ex. 8-30) stated: In the descripUon of the chemical hygiene plan* * * the rules call for ``additional employee protection for work with carcinogens or potential carcinogens aa defined herein" * * * The problem is that weak and negligible carcinogens (using the OSHA definition of a carcinogen) would be included * * * Including weak or negligible carcinogens in the list of chemicals that require additional employee protection would actually do a disservice to employees because it would dilute the attention paid to Federal Register / VoL 55. No. 21 / Wednesday, january 31. 1990 / Rules and Regulations 3319 the hazards involved in the use of truly toxic underemphasized the hazards of acutely After careful consideration of the materials. , toxic substances. He stated: evidence presented regarding the Conoco (Ex. 0-69) stated; Conoco appreciates the difficulty of defining "toxic substance" in order to . . > . . prescribe appropriate work practices-for. , - carcinogens and potential carcinogens.: However, the standard as written does not permit the employer to take into account the "Carcinogenicity or cancer-production is only one of many possible manifestations of harm from a toxic substance. Acute poisoning resulting in . death or permanent injury are other . manifestations which should be of equal concern." (Ex. 8-29). proposed approach to handling .. carcinogens. OSHA has made the following decisions with respect to the final standard:. (1) Narrowed the definition to "select carcinogen" to connote a category of chemicals where the evidence strongly potential health hazards related to relative The Environmental Protection Agency indicates human carcinogenicity; potency and degree of exposure. Conoco is (Ex. 10-1) supported the special (2) Considered carcinogens in the concerned that without such flexibility the standard will needlessly burden employers by requiring restrictive work practices, such as regulated areas, which are not justified by the potential health risks presented because either the quantities are minute or the - handling provisions for carcinogens but suggested the need for additional protective measures for highly toxic substances which were not necessarily carcinogenic. context of laboratory work as only a subset of other particularly hazardous substances; and : (3) Allowed employers flexibility to . assess the need for additional protective exposure is minimal. . . . ,, The Standard Oil Company (Ex. 8--12} . measures and to determine the . . Genencor Inc. (Ex. 8-51) stated: ' questioned the rationale for requiring . appropriate precautions to effectively special carcinogen provisions. With . control exposures to particularly In the proposed standard, alt carcinogens respect to the carcinogen provisions. hazardous substances, including * are to be handled with the same level of " control without regard to relative risk.' - <Jquantity handled, concentration, physical -! properties (solid, liquid, vapor pressure) and method of use. This is not in accordance with the issuance of a performance standard or good industrial hygiene practices. Los Alamos National Laboratory suggested that the proposed carcinogen . provisions were appropriate for certain carcinogenic substances and certain use conditions but also pointed out the need - : for more flexibility as stated in the _ following excerpt: .- Standard Oil commented as follows: * * * (Sjince OSHA does not require these or similar stringent practices far chemical substances having other toxic effects such as teratogenicity, mutagenicity or extreme acute toxicity OSHA apparently believes that the implementation of prudent laboratory practices will generally afford adequate protection from these hazards.- Finally, there were comments (sea e.g.. Exa. 8-19, 8-38, 8-42. 8-54, 8-66. 883, 8-107, 8-117.8-116 and 10-9) which .. recommended that OSHA allow more ', flexibility in determining how best to '. , carcinogens. - Because the Hazard Communication Standard used the term, "carcinogen," in its definition of "hazardous chemical" (see appendix A of the HCS) and this standard tries to be consistent with the HCS definitions, it was necessary to distinguish the broad range of carcinogens covered in HCS from the narrower range covered in these special provisions of the laboratory standard. For this reason, the new term, "select carcinogen," was coined which refers to the subgroup of carcinogens for which Substances proven to be carcinogenic to humans or demonstrating high carcinogenic potency in animals should be controlled extremely well as proposed. However, the standard should allow for less stringent requirements where the operation involves only very dilute solutions (for example <0.1 or o.oi percent depending on the potency of handle particularly hazardous there-are special considerations in this ; substances, including known carcinogens. Consider, for example, the - standard. - . In accordance with the comment submitted by Exxon Research recommendations in the comments and Engineering Company (Ex. 8-96). regarding which carcinogens should be C.R. Lipuma. Manager of Technology subject to special provisions. OSHA has Support commented: designated four categories of the substance), or the substance has demonstrated carcinogenic potency only under high doses. (Ex. 8-20). In addition to the concerns expressed in the comments discussed above, there were others that pointed out that there are numerous substances used in . laboratories which present hazards both chronic and acute as severe as those presented by carcinogens. Dr. Emmett Barkley of the National Institutes of Health, for example, suggested that the regulatory approach taken in the proposal inappropriately implied that ' * * (IJt has been and still is in the best carcinogens to be referred to as "select interest of research laboratories to take the approach of following good laboratory practices. This not only applies to potential carcinogens, but reproductive risk source materials and chemicals that have specific organ effects e.g.. hepatotoxins. neurotoxins carcinogens" and therefore subject to special consideration in the employer's Chemical Hygiene Plan. For the purposes of this standard, "select carcinogen'' includes any substance and the like. We believe the current emphasis which meets one of the following on certain specific chemicals because they criteria: (1) Is regulated by OSHA as a are suspect carcinogens, could result in employees in certain areas being over cautious or even refusing work based on emotional response due to unnecessary extra attention. Simultaneously, these same employees may reduce their respect for other carcinogen or (2) is listed under the category, "known to be carcinogens." in the Annual Report on Carcinogens published by the National Toxicology Program (NTP) (latest edition); or (3) is potentially hazardous material. We need to listed in Group 1 ("carcinogenic to carcinogens may be the most hazardous assure all employees follow procedures to of toxic substances to which laboratory Workers may be exposed. He stated: protect themselves from the event of ' chemical exposures of any kind. humans") by the International Agency for Research on Cancer (IARC) (latest . edition of Monograph). "This is not the case. There are The comment from Hoffman-LaRoche In addition, a substance listed either numerous chemicals whose acute Inc. (Ex. 8-111) emphasized the need for . by NTP under the category, "reasonably toxicity is more hazardous than any flexibility in determining when specific anticipated to be carcinogens," or listed currently regulated carcinogen." (Ex. 14. additional precautions are called for. P-4). . . . .- The comment stated: "lS]ome degree of by IARC in Group 2A or 2B shall be considered a select carcinogen only if it Similarly, Stephen R. Larson. Director flexibility should be accorded to the has "additional qualifications;1' that is. of the Office of Environmental Health employer in deciding the circumstances . -has been shown to cause significant Safety at Northeastern University under which a regulated area is needed tumor incidence in experimental Su8gested that the proposed standard . - .or whether a fume hood or other closed animals in accordance with any of the 0veremphasized carcinogens and system is required." . following criteria: (a) After inhalation VVV 000011167 3320 Federal Register / Vol. 55, No. 21 / Wednesday, January 31, 1990 / Rules and Regulations exposure of 6-7 hours per day, 5 days per week, for a significant portion of a lifetime to dosages of less than 10 mg/ m3 (b) after repeated skin application of less than 300 mg/kg of body weight) per week; or (c) after oral dosages of less than 50 (mg/kg of body weight) per day. (Group 2A, according to IARC. is usually reserved for exposures for which there was at least limited evidence of carcinogenicity to humans. Group 2B, according to IARC, usually refers to the combination of sufficient evidence in animals and inadequate data in humans.) Chemicals falling under lARC's Group 3 ("could not be classified as to their carcinogenicity in humans") are not considered as select carcinogens under this standard. This does not mean, however, that OSHA disputes the evidence linking these chemicals with . carcinogenicity: it merely indicates that the Agency believes that the provisions of the Chemical Hygiene Plan outlined in the standard, if properly implemented, will adequately protect employee working with these substances. If data corresponding to these criteria do not appear in the IARC or NTP documentation or in other existing literature for these substances, then they need not be treated as "select carcinogens'* under this standard. - _ . However, it is the responsibility of the employer to determine whether such data exist. The "additional qualifications" for - substances listed by IARC and NTP for which definite carcinogenicity in humans has not been established were added in response to the many participants who were concerned that the definition as previously proposed would require special treatment for substances which had demonstrated only limited evidence of carcinogenicity. These criteria, designed to establish that a given substance exhibits moderate to high carcinogenic potency, are taken from the National Research Council's 1901 report, "Prudent Practices for Handling Hazardous Chemicals in Laboratories" (Ex. 7-13). OSHA included a discussion of these referenced criteria in the proposed standard (51 FR 26672). However, at the time OSHA felt their inclusion might require extensive literature searches or laboratory experiments which OSHA believed might be unreasonable where only small amounts of these substances were used. Certain comments, however, recommended that employers be allowed to make such evaluations (see e.g., Exs. 8-14. 8-19, 8-36, 8-118 and 109). Consequently, OSHA has decided that it would be more effective to allow the individual laboratory to make the determination as to whether a substance listed under NTFs category, "reasonably anticipated to be carcinogens" and IARC Groups ZA or ZB meets the criteria of moderate to high carcinogenic potency before requiring the special considerations prescribed in the final rule. In addition to narrowing the definition of carcinogen by using the new term '`select carcinogen" in the final rule, the Agency has considered carefully comments that questioned the selection of carcinogens alone for special emphasis in the Chemical Hygiene Plan. On the basis of concerns expressed in the record, OSHA has decided not to confine the need for special consideration to carcinogens only. Therefore, OSHA has decided to add ' substances with high acute toxicity and reproductive toxins to select carcinogens as substances which will need special consideration in the Chemical Hygiene Plan. Reproductive toxins may manifest themselves in lethal effects on the fertilized egg, developing embryo or fetus or teratogenic (malformation) effects in the fetus. In addition, certain reproductive toxins may cause infertility in females and males. Substances with high acute toxicity such as hydrogen cyanide, hydrogen sulfide and nitrogen dioxide are included under the category of substances for which employers must consider the need for special precautions. Such substances may be fatal or cause damage to target organs as a result of a single exposure or exposures of short duration. OSHA believes that employees should be made aware of the deleterious effects of these categories of substances discussed above through effective training which is reinforced where appropriate through written procedures in the employer's Chemical Hygiene Plan. A number of commenters (Ex. 8-32. 835. 8-65, 8-66. and 8-87) objected to the inclusion of special mandatory provisions for designated substances such as carcinogens, stating that this would unnecessarily impinge on the employer's flexibility to deal with the hazards presented in their laboratories in the most expeditious manner. OSHA still believes that special consideration and emphasis may be needed when dealing with substances that are particularly hazardous. However, because of the wide degree of exposure and use conditions that may affect the actual degree.of hazard to workers in a given situation, OSHA is providing the employer some added-flexibility in the final rule. Employers are required to focus their attention on certain types of substances and at least consider protective procedures for such substances explicitly in their Chemical Hygiene Plans, but the specific procedures which were required by the proposal are required by the final rule only where the employer has determined them to be appropriate. The provisions that must be included where deemed appropriate by the employer for work with select carcinogens, reproductive toxins and substances with a high degree of acute toxicity are: (l) The establishment of a designated area; (2) use of containment devices such as fume hoods or glove boxes: (3) procedures for safe removal of contaminated waste; and (4) decontamination procedures. OSHA has replaced the term, "regulated area," with "designated" area in the final standard in response to comments that objected to the proposed provision. The definition of a regulated area as proposed meant a laboratory, an area of a laboratory or device such as a laboratory hood for which access is limited to persons who are aware of the hazards of the substances in use and the precautions that are necessary. In particular, Exs. 8-12, 8-24. and 8-68 voiced concern regarding this provision. Vista Chemical Company, for example, commented: The establishment of regulated areas for work with carcinogens in laboratories and laboratory areas is unpractical in many cases and inconsistent with the criteria used for the establishment of regulated areas in other standards. Laboratory fume hoods are seldom dedicated to one type of chemical use in manufacturing quality control labs ' * * Use of carcinogenic material requiring the establishment of a -regulated area is seldom continuous. (Ex 8-80). OSHA recognizes that even though the definition of a regulated area used in the proposed standard was significantly different from the way it is usually defined in other OSHA standards, it may have been interpreted the same. In OSHA's substance specific standards, regulated areas are required to be established where exposures to the substance exceed the PEL In these instances an actual demarcation i9 implied to set these areas aside from other areas of the workplace and access is restricted to authorized personnel, thereby limiting the number of workers exposed. Typically, a medical surveillance program is required to be established and implemented for employees assigned to a regulated area. In other OSHA standards, such as those regulating the 13 Carcinogens, for wv 00001116a Federal Register / Vol. 55, No. 21 / Wednesday. January 31, 1990 / Rules and Regulations 3321 example, {see 29 CFR 1910.10031910.1016) employees working in substances of high acute toxity for other out such responsibilities. There was workers present in the designated area. only minimal comment in the record regulated area needed to use special The provisions in the proposed which specifically addressed the need protective clothing and to shower before leaving the plant. OSHA recognizes that exposures of this magnitude are not typically found in laboratories, and given the nature of laboratory operations, restricted access to a work area or other restrictions may not be practical. However. OSHA believes that in the case of work involving select carcinogens, reproductive toxins and substances of high acute toxicity, especially in work areas where other less toxic chemicals are being used , simultaneously, some method of limiting exposures and alerting all workers in the vicinity to the potential hazard may be warranted. Therefore. OSHA is using the less restricive term, "designated area." in the Fmal standard, A ' "designated area" differs from a regulated area in that the only duty associated with it is to post the area and assure that all employees working in the area are informed of the hazardous substances used there. , Under the final standard, fume hoods or equivalent containment devices are required to be considered by the employer for handling "select carcinogens." reproductive toxins, and substance with high acute toxicity only in certain circumstances. Circumstances'' that may require the use of containment devices include: the use of volatile substances, manipulations that may result in the generation of aerosols; and any manipulation, handling or reaction that may result in the uncontrollable release of the substance. (These were adopted from various safety guidelines including the "NIH Guidelines for the Laboratory Use of Chemical Carcinogens" and "Handling Chemical Carcinogens in the Laboratory Problems of Safety," 1ARC Scientific Publications No. 33, as well as from comments (see Exs. 8-66. 8-111 and 10-9) submitted to the record). Because the "designated area" as used in this final standard is not as restrictive as the "regulated area" used in the proposal, and access is not limited. OSHA felt that it was essential to require employers to consider an standard which required employers to specify appropriate protectives apparel to be worn by employees while working for employers to assign an employee to develop and carry out the Chemical Hygiene Plan. Moreover, record within a regulated area and specify - evidence, including information in the appropriate hygiene practices have been Booz. Allen and Hamilton Laboratory deleted from the final rule with respect to designated areas since OSHA Profile Study (Ex. 7-11), indicates that many employers currently have an believes that this concern is already employee assigned to safety and health adequately covered under the general requirements of the Chemical Hygiene responsibilities associated with their operation. OSHA believes that such Plan. actions attest to the recognized need The proposed Chemical Hygiene Plan that an effective employee protection also included provisions requiring the program such as that required by the employer to evaluate laboratory Chemical Hygiene Plan can best be operations and specify the criteria for achieved if coordinated and operations that would need prior implemented by an individual assigned approval. Clearly, an employer might to cany out such functions. decide that certain operations involving There is further evidence in the record highly toxic noncarcinogenic material or which suggests that even though highly volatile toxic material needed laboratories have assigned individuals prior approval and impose additional to oversee safety and health concerns, precautions at the time of such approval. in many cases these individuals are not In addition, the final standard - given the necessary authority to instructs employers to pay particular . " successfully carry out their attention to the selection of controls for responsibilities. See. for example, the any other chemicals known to be testimony of Dr. Alan Todd, Director of extremely hazardous. ., Industrial Hygiene. Stewart-Todd The employer's Chemical Hygiene - _ , Associates. Dr. Todd stated; ' Plan shall also make provision for ^ * * * [IJt is all too common to find that the employee training and information, safety officer who's typically a senior staff medical consultation and examine tfons. . member has been saddled with the health However, for purposes of clarity these and safety responsibility. At the same time, elements are included in the final standard under separate paragraphs and merely referenced in the CHP. The final standard also requires that they are not given the authority to follow through in exercising reasonable control of laboratory materials and activities by their peers or those who work for them (Tr. B9J. employers designate a Chemical The fact that OSHA is now requiring Hygiene Officer to provide technical that employers designate a chemical assistance in the development and hygiene officer should provide administration of the Chemical Hygiene Plan. If deemed appropriate, the employer may establish a Chemical considerably more authority and responsibility to persons who function in this capacity. Hygiene Committee to assume this function. The designated individuat(s) must be qualified by experience or Another concern expressed in the record was that the Chemical Hygiene Plan required by the Laboratory training to carry out these Standard duplicated many of the responsibilities. However, OSHA intentionally did not define the skills needed to qualify as a Chemical Hygiene Officer since the requisite provisions of the Hazard Communication Standard. (See. e.g. Exs. 8-21. 8-32. 8-33. 8-35. 8-i2. 8-47, 8-52. 8- 54. 8-64, 8-85, 8-88. 8-96. 8-101, 8-105. background experience and qualification would vary according to and 8-112.) In particular, commenters questioned the need for a written the complexity of the operation. Chemical Hygiene Plan in case9 where Similarly, the final standard does not laboratories associated with mandate what position or job manufacturing operations have additional provision for the protection of classification the designated individual laboratory workers. The new provision must hold in the employer's expanded the HCS program to all employees regardless of whether their requires the employer to consider organizational structure. This is left work is in production or laboratory whether decontamination procedures for entirely up to the employer. For operations. Some commenters. among the "designated area" are appropriate. example, the chemical hygiene those cited above, requested that OSHA These procedures would vary with the responsibilities might be assigned to an allow laboratories the option to comply type of substance used. OSHA believes individual presently serving as the with either the Laboratory Standard or that such a provision may be necessary safety officer, to a laboratory supervisor the Hazard Communication Standard. to minimize potential exposure to select : or to any other employee considered by In response to this concern, OSHA carcinogens, reproductive toxins and the employer to be capable of carrying believes that several points should be VVV 0000X1169 3322 Federal Register / Vol. 55, No. 21 / Wednesday. January 31. 1990 / Rule9 and Regulations considered. First, there isra basic difference between the intended objectives of the Laboratory Standard and those of the Hazard Communication Standard. The goal of the HCS is to communicate to employees the hazards Paragraph (f) Training and Information In the preamble to the proposed - laboratory standard, OSHA proposed that the training and information provisions supersede those of the Hazard Communication Standard Laboratory work can be extremely variable and can range from the more routine quality assurance work, which utilizes the same materials day after day. to basic research work where the materials may change daily. The HCS requires training and education each time a new hazard is introduced. In of chemicals in the workplace. The employer's duties with respect to the HCS are directly related to the communication of information regarding hazards, including a description of any specific control measures that have been (HCS). [See 51 FR at 26661.) At the time the proposed standard was published, only laboratories in the manufacturing sector (SIC codes 20-39) were covered by the HCS training provisions. Since then, the Hazard Communication basic research type operations, this could be frequently. More general type training with a reference library or information source is preferable in achieving the desired goal of each individual feeling responsible for his or her own health and safety. (Ex. 8-112). established to protect employees. The Standard was expanded to include Similar support was offered by E.1. Du HCS. however, does not mandate the laboratories and other businesses in Pont De Nemours & Company: use of recommended control measures, but merely requires that information about appropriate control measures is non-manufacturing sectors as wetL (52 FR 21852, August 24,1987). The training provisions of the The proposal as presented is well suited to laboratory operations. In many respects it parallels the HCS requirements. 1! also communicated to the employees. proposed laboratory standard and the supplements the HCS requirements in order The Laboratory Standard, on the other HCS are similar in intent; the major hand, is designed to provide a differences are summarized as follows: comprehensive approach for the First, the proposed laboratory standard protection of laboratory workers which required that employees be trained only is more appropriate to laboratory in areas related to health hazards. The conditions than compliance with the substance specific standards in 29 CFR HCS requires training for both physical and health hazards. Second, in lieu of part 1910, subpart Z. The Laboratory specific training or chemical hazards, Standard requires that employers the proposed standard required that protect workers through the development and implementation of employees be informed of available references pertaining to the hazards and work practices and control measures safe handling of toxic substances. The expressly tailored to the individual HCS explicitly requires that employees laboratory workplace. be trained in methods and observations Both standards require that employees to detect the presence or release of _ be trained regarding the hazards of tbe chemicals to which they may be exposed. For the most part, the training provisions required by the Laboratory Standard are identical to those of the HCS. There are, however, several additional training elements which are specific to the laboratory standard and the chemical hygiene plan in particular. For example, the employee shall be trained on the details of the Chemical Hygiene Plan which includes standard operating procedures, prior approval hazardous chemicals in the work area "and protective measures including those instituted by the employer. OSHA's rationale for the approach to training taken in the proposed laboratory standard was based in part on the evidence available at that time. This evidence indicated that, given the qualifications of laboratory personnel, the multiple chemicals typically used and changing procedures, the proposed training requirements were more relevant to laboratory operations than were the HCS provisions. OSHA. protocols, and procedures for handling however, solicited comments as to select carcinogens, reproductive toxin9, whether the training section should and substances with a high degree of acute toxicity where appropriate. In more closely mirror the provisions of the HCS. addition, employees shall be informed of The training provisions of the the location and availability of known - proposed standard were supported in reference material pertaining to the several of the comments submitted (Exs. hazards, safe handling and disposal of 8-19. 8-39,8-76.8-107,8-112, 6-118. and chemicals in the laboratory. OSHA does 10-17). For example, Dow Chemical not believe that these provisions which Company stated: are felt to be essential for the protection of laboratory workers will result in undue compliance burdens. OSHA asks for comments or whether tbe training and education section of this proposal should more closely mirror those of Finally, wherever there may be tbe HCS. We believe the performance to respond lo training needs specific to laboratories. Changes in the proposal (o make the provisions Identical to the requirements for industrial plants would render them less effective for laboratories. (EX. 8-19.) In contrast others (Exs. 8-9.8-20. 823,8-38, 8-66. 8-70,8-75, 8-91. 8-97. 8- 98, Tr. 135 and Tr. 234) suggested that the proposed provisions were not sufficient to effectively apprise workers of the hazards and precautions necessary to 9afeiy handle toxic substances in laboratories. For example. Dr.j. H. Carver commenting as a private citizen and Senior Genetic Toxicologist stated: The training and education sections of the Proposed Chemical Hygiene Plan appear to be inadequate as outlined; they should adhere more closely to those provisions of the Hazard Communication Standard which requires training in the physical and health hazards of the chemicals in the work area. Information regarding available reference material is not sufficient (Ex. 8-9.) In his testimony presented at the informal hearing, Norman Steere, consultant in laboratory safety, expressed the following views on the proposed training provisions: I do not believe that the elements of the training program required by the proposed standard are sufficient to achieve effective communication about hazards and precautions for laboratory employees. Merely informing employees of the availability of reference material on the hazards and safe handling of toxic substances will not be effective unless the employee is highly . motivated, and given on-the-job time to team the necessary technical terminology and study the reference material. (Tr. 135). duplication of any requirement, there is no need to perform the function twice. If an employer is complying with the Hazard Communication Standard, either by choice or necessity, his activities will automatically satisfy any identical requirement of this standard. oriented approach of this present proposal is Additional comments asserted that more appropriate for laboratory personnel. although many laboratory workers are As OSHA has been told many times, laboratory work is usually done by, or under the direction of highly trained personnel. The ' individuals usually have inquiring minds, and ' trained in particular sciences, this fact does not obviate the need for specific training regarding hazards and safe if informed where or how to get additional handling of chemicals with which they information on a substance, will seek it out. work. Such views were reflected in the VVV 0000X1170 Federal Register / Vo!. 55, No. 21 / Wednesday, January 31, 1990 / Rules and Regulations 3323 comments of the Los Alamos National Laboratory: " * *" * We strongly believe that the training requirements should go beyond only informing employees of available reference materials on the hazards of chemicals in the work area, and should include actual training on the health and physical hazards of the chemicals. Although many laboratory personnel have advanced degrees and are highly competent in their fields of study, that does not make them expert in the hazards associated with chemicals. The hands-on work with chemicals will also often be . performed by a technician whose training was primarily acquired on the job. and who has very little knowledge of the hazards that may be involved Those with advanced degrees sometimes demonstrate a cavalier attitude towards the potential hazards, and it is important that laboratory employees receive training to recognize hazards. (Ex. 820). Dr. Inara Brubaker, testifying on behalf of the American Chemical Society, agreed that laboratory workers were highly trained with respect to their particular scientific disciplines but pointed to a deficiency in the training provisions of the proposed standard. Dr. Brubaker testified: Most laboratory workers are highly trained ' in the sciences, and when they are not. they are usually supervised by someone who is * * * This training has provided these professionals with a better background than most workers as to the hazards, exposures and appropriate means of protection in handling toxic substances. However, since safe work practice decisions are often made by the laboratory worker a comprehensive training program is the single moat important aspect of worker protection The proposed training and safety program falls short of informing laboratory employees of potential hazards to which they may be exposed. Merely informing workers of available reference material "will not be sufficient to ensure employee health and safety. The ACS believes that the training * * should be at least as extensive as (hat required by the Hazard Communication Standard " (Tr. 234-235). In contrast, others objected to OSHA's proposal to have the training provisions of the laboratory standard supersede the provisions of the HCS. For example. Public Citizen stated: * * " While manufacturing workers (and *oon all workers, when OSHA expands the HCS as it has been instructed to do so by the Court) have a right to be educated about the *pecific hazards of the chemicals they handle, laboratory workers will not have this ^ght because the proposed standard would fixempt laboratories from this facet of the HCS. (n contrast, the proposal would merely Squire employees to be informed of . Available reference materials on laboratory hazards. Thus, meaningful training 'tquirements are shipped away, and workers are left with what they already have--the Ppnrtunity for self-education. lEx. 8-70). After careful consideration of the emergency procedures: and the details complete record. OSHA has concluded of the employer's Chemical Hygiene that relevant portions of the HCS Plan. training and information section, with Since this is a performance oriented appropriate modification, should be standard, the amount and complexity of incorporated into this standard. the training which must be implemented The proposed training provisions may will vary with the complexity of the have relied too heavily on information operations and the potential hazards. which suggested that most laboratory The final standard therefore requires personnel were already knowledgeable that employers provide employees with about the hazards related to the information and training so that they chemicals with which they work and the will be apprised of both physical and precautions necessary to protect health hazards associated with themselves. Record comments {see e.g. hazardous chemicals present in their Tr. 134-136, and Tr. 382) indicate this - workplace. Such information and cannot be assumed to be the case for all training is to be provided at the time of laboratory workers. Even those with the employee's initial assignment and advanced degrees are not necessarily prior to assignments involving new trained in the safety and health aspects hazardous chemicals or new exposure associated with chemical exposures. OSHA also agrees with the '' recommendations in the record that laboratory employees should have the benefit of training in physical hazards. Physical hazards are often responsible for subsequent adverse health effects, e.g., explosions and lire could lead to the release of toxic fumes and vapors to which employees may be exposed. Moreover, the failure to require training concerning the potential physical- hazards posed might encourage a false sense of security concerning the range of hazards presented. In reaching its decision to incoroprate the HCS training provisions into this final standard. OSHA also considered the experience that labortaories in the manufacturing sector have had with the Hazard Communication Standard. These laboratories have been subject to the HCS training provisions for several years. In addition, laboratories outside situations. The required training does not necessarily involve training for each specific chemical that the employee will use but rather the approach may be directed to classes or groups of hazardous chemicals. In addition, information to be communicated and made available to employees include the following: (1) The contents of the final standard and its appendices: (2) the employer's Chemical Hygiene Plan; (3) The PELs for OSHA regulated substances used in the work area and recommended exposure limits for other hazardous chemicals in the absence of an OSHA standard: (4] signs and symptoms associated with exposures to ' hazardous chemicals used in the laboratory; and (5) the availability of reference materials on the hazards, safe handling, storage and disposal of hazardous chemicals. Reference material would include, but not be of the manufacturing sector were required to come into compliance with limited to. MSDSs that may be available from chemical suppliers. the HCS training provisions by May 23, Pertinent reference materials 1988. OSHA believes that to introduce concerning the hazards, safe handling, completely different requirements for storage and disposal of hazardous employee training in the final laboratory chemicals used in the laboratory are an standard might be unnecessarily essential part of an effective employee confusing to employers and employees protection program. As required by the as well. With the framework of the Hazard Communication Standard, such training program already in place under hazard information is to be provided by the HCS. OSHA.believes that the the material safety data sheet that modifications to existing laboratory accompanies the shipment of the training programs necessary to chemical. However, in the event such accommodate the provisions added by information is not received or is the final laboratory standard are incomplete, or in cases where the minimal but essential for an effective chemical is generated by the laboratory, training program for laboratory workers. additional reference material may be Employee training shall include the necessary. The final standard requires methods and observations that may be that where reference material, including used to detect the presence of hazardous material safety data sheets, are known chemicals in the work area including to be available, the employer shall any measures that the employer has inform employees of their location and instituted; the physical and health availability. The standard places no hazards associated with chemicals in restrictions on the form in which the work area and appropriate reference materials should be kept, and protection measures including some employers may wish to utilize vvv 00001.1171 3324 Federal Register / Vol. 55, No. 21 / Wednesday. January 31. 1990 / Rules and Regulations computer technology. This*format is acceptable as long as employees are aware of the procedures necessary to access the information from this source. Paragraph (g) Medical Consultation and Medical Examinations At the time the standard was proposed, OSHA's available information indicated that, given the multiple chemicals used and the unpredictable . exposure situations typical of most laboratory operations, exposure monitoring was not practical. Additionally, routine medical surveillance was indicated to be prohibitively expensive and have little value because of the wide variety of substances lo which workers were exposed and the difficulty in identifying indicators of adverse health effects, OSHA. however, recognized that the potential for overexposure still existed and attempted to strike a balance in the proposal between adequate medical monitoring and practical utility. The proposal required employers to provide employees with an exposure evaluation in cases where there was reason to believe overexposure to a toxic substance had taken place. The exposure evaluation would be conducted by the Chemical Hygiene Officer and would provide an assessment of the conditions associated with the suspected overexposure. Among the factors to be considered in conducting an exposure evaluation were the chemical and physical properties of the substance involved, the quantity in . use, the potential for overexposure associated with the operation involved and an estimation of the duration of exposure (51 FR at 26673). If the. exposure evaluation indicated that an overexposure was likely to have occurred, the affected employee would be given an opportunity for medical consultation. The consultation included physician review of the exposure evaluation results and a conference with the affected employee, if necessary, to determine the need for medical examinations in a particular instance and. if indicated, follow-up medical procedures. OSHA's proposed approach to medical protection for laboratory workers was supported by several participants in their response tothis issue. For example. Dr. W. Emmett Barkley, former Director of the Division of Safety at the National Institutes of Health testified as follows: The provisions for exposure evaluation and medical consultation are sensible for most compounds and uses in the laboratory, and they reflect the current state of knowledge regarding the efficacy of medical surveillance initiatives within the laboratory setting. Overt exposures to toxic substances should initiate thorough evaluation to assess the degree of exposure. If It Is determined that an overexposure has occurred, it is imperative that employees be provided with medical consultations and follow-up treatments, as necessary. (Tr. 111). Further support was presented in the comment submitted by the Chemical Manufacturers Association (CMA): We agree fully with the proposal that each chemical hygiene plan should provide for medical consultation in all cases where an exposure evaluation indicates the likelihood of overexposure. Such consultations should be followed up by medical examinations or medical surveillance if recommended as a result of the medical consultation. (Ex. 8-65). Other comments agreed with parts of OSHA's exposure evaluation/medical proposal. For example, the comment submitted by Vulcan Chemicals stated: While the provision for an exposure evaluation for employees who may have been overexposed to a toxic substance is a reasonable requirement, the requirement for a mandatory medical consultation for such employees is ill conceived. The exceedance of the OSHA permissible exposure limit or the ACGIH TLV does not automatically place an employee at such a risk that medical consultation is necessary * a * The PEL or TLV describes an exposure level to which an employee may be exposed for a working lifetime without harmful effects. Thus, the mere exceedance of this level may not result in a harmful effect, (Ex. 8-68). However, other comments related to this issue recommended that OSHA require employers to institute a more comprehensive approach to ensure that employees have the full benefit of an appropriate medical protection program. See, for example, Exs. 6-15. 6-23, 8-38. 8-50,8-70, 8-75, 6-70, and Tr. 48 which share the concerns expressed by the U.S. Department of Agriculture: The proposed rule includes provisions for an exposure evaluation and medical consultation whenever an employee may have been overexposed to a loxic substance * * * However, the proposed rule lacks a preventive health orientation by linking these provisions to only incidents of suspected or actual over exposure to toxic substances * * * (Ex. 10-6). The requirement for an exposure evaluation as a means to trigger medical consultation for employees was criticized by several participants. For example, Maureen Hamilton, CIH, Director of Environmental Health Sciences at NHS, Inc. stressed the impracticality of this provision. She Stated: The use of "exposure evaluations" when an employee feels he or she has been overexposed to a toxic substance is impractical. Trying to recreate a situation after the fact is virtually impossible and always open to debate. (Ex. 8-84). Dr. Daniel Teitelbaum, Director of Medical Toxicology at Denver Clinic Medical Centers and expert OSHA witness was opposed to the exposure evaluation concept for different reasons. Dr. Teitelbaum testified as follows: I do not believe that employees should be required lo be approved for a visit to a physician by a non-health professional when a potentially serious exposure to a chemical hazard is believed by the employee to have occurred. On the contrary, the employee should be encouraged to seek consultation from a physician or occupational health nurse at once if there Is a reasonable belief that an exposure to a toxic substance has taken place* * * It is often not appreciated that following exposure to many chemicals, there is a golden period during which appropriate treatment may prevent the occurrence of serious and life-threatening illness. If one delays treatment for these injuries until after the symptoms begin. the patient may suffer increased morbidity or die because treatment is given too late. (Dr. Daniel Teitelbaum. Tr. (43-44).) After careful consideration of the information submitted with respect to the exposure evaluation as a mechanism to determine the need for medical consultation for affected employees, OSHA agrees that this approach would rely too heavily on subjective judgment. As Dr. Teitelbaum pointed out in his testimony (Tr. 43-44) on this issue, a non health professional such as the Chemical Hygiene Officer may not necessarily recognize the nuances that influence appropriate judgment calls. For these reasons, this approach is not used in the final standard. Some commenters recommended a more comprehensive approach to medical coverage for laboratory workers than that outlined in the proposed standard, citing the benefits of baseline medical examinations, periodic . reexaminations and medical surveillance (see e.g. Exs. 8-15, 8-22, 8- 38. 8-70 and 8-76). However, it is important to note the experience of a major research center, the National Institutes of Health. According to Dr. W. Emmett Barkley,' former Director of the Division of Safety, in the past, the NIH applied the "kitchen sink" approach in its efforts to implement a medical program for laboratory workers. * * (F]or 10 years we had what I will call a "kitchen sink" approach to medical surveillance. Annually, we provided everything we thought was relevant to physical examinations. We recorded every compound for which people used in their work, both viruses and chemicals, and we evaluated this after a six-year use period, and VVV 000011172 Federal Register / Vol. 55, No. 21 / Wednesday, January 31, 1990 / Rules and Regulations 3325 found that it was not effective es a means for addressing worker safety. The resources th at we put into that could aiore~feffectively be used to monitoring the processes by which people carried out their work end educating and enforcing practices more vigorously."(Tr. 120). Dr. Barkley subsequently described the role of medical consultation es used at the NIH: We do, however, provide medical consultation for any situation where an overt exposure to a chemical or biological system occurs, whether it be through inhalation, skin contact self-innocuJation or what have you. We feel that this is very, very important not only to maintain a record of the event, but to see whether there are processes or procedures that we could follow to see whether there was the degree of exposure, and we also look at it from the standpoint of how we might prevent this occurrence again. (Tr. 121). In deciding the type of medical program that would be appropriate for laboratory workers, it is important to keep in mind the nature of exposure conditions in a typical laboratory covered by this standard. Typically, chemicals used and procedures performed change frequently. Moreover, according to information in the record, it is not always known in advance which chemicals will be involved in a laboratory procedure. (See, for example, Ex. 3-72 and Ex. 7-2.) OSHA believes that these conditions seriously confound-., the effectiveness of a medical surveillance program. Similarly, OSHA is not convinced, given the unpredictable array of chemicals in laboratories, that general baseline examinations would provide meaningful correlation in the event of future adverse exposures unless certain conditions are known in advance. In reaching this conclusion. OSHA does not suggest that medical provisions are not needed under any circumstances to protect laboratory workers. The difficulty arises in establishing a rational approach as to when such provisions should apply. Clearly, if an employee exhibits signs or symptoms related to exposure to a hazardous chemical or if an employee is subjected to events such as spills, leaks, explosions or other unexpected occurrences where there is a likelihood of exposure to hazardous chemicals, that employee should be afforded an opportunity to receive appropriate Medical attention. The final laboratory standard Provides for medical attention under these circumstances. Specifically, the standard requires that employers Provide employees with an opportunity to receive appropriate medical examinations whenever the employee exhibits signs or symptoms associated with exposure to a hazardous chemicaL The employer shall also provide employees with an opportunity to receive a medical consultation whenever an event takes place in the work area such as a spill, leak, explosion or other occurrence resulting in the likelihood of a significant exposure to a hazardous chemical. The medical consultation is provided for the purpose of determining the need for a medical examination. The employee shall be afforded an opportunity to -- receive any examinations recommended by the physician. All medical examinations and consultations shall be performed by or under the direct supervision of a licensed physician and shall be provided at a reasonable time and place without cost to the employee. OSHA believes the situations described above should be covered as a minimum in any medical program designed for laboratory workers. However, beyond the circumstances just mentioned and on the basis of the rulemaking record, OSHA has provided additional protection in the event that workplace exposures routinely exceed those extremely small exposures upon which this standard was predicated. In the earlier discussion in this preamble concerning Employee Exposure Determination (paragraph (d)), exposure conditions are described under which . the employer must comply with the medical and monitoring provisions of a relevant standard that are triggered by exposure over an action level (or PEL where there is no action level). Those conditions involve routine exposure levels in excess of an action level (or PEL in the absence of an action level] for an OSHA regulated substance for which there are monitoring and medical surveillance requirements. The result of the addition of this provision is that if there appears to be an identifiable condition in terms of overexposure, i.e., exposure levels above the action level (or in the absence of an action level, the PEL), signs or symptoms of exposure, or the occurrence of an unusual event such as an explosion, leak or spill, then medical attention will be provided. In view of the foregoing evidence OSHA believes that the provision of the final standard with respect to employee medical protection is sound and adequately protective of employee health. It is also reasonably necessary and appropriate to achieve this goaL Paragraph (h). Hazard Identification OSHA's proposed laboratory standard did not include special provisions for labeling. Kowever,.OSHA solicited comments regarding the need for such provisions. (51 FR at 26678). Among those commenters who responded to this issue, several (see Exs. 8-48.8-79, 6-106 and 8-108) specifically recommended that OSHA retain for this standard the labeling requirements of HCS as they pertain to laboratories. OSHA believes that thi3 action is appropriate. OSHA also recognizes that labeling practices may best be implemented by the individual employer as part of the Chemical Hygiene Plan. Therefore, the requirements of OSHA's Hazard Communication Standard concerning retention of labels and material safety data sheets accompanying incoming shipments of hazardous chemicals have been incorporated into this standard. This action doe9 not represent an increased obligation on employers. Employers are to ensure that labels on incoming containers of hazardous chemicals are not removed or defaced. In addition, material safety data sheets which accompany incoming shipments of hazardous chemicals are to be maintained and made accessible to employees. To avoid any confusion which could arise regarding hazard identification relating to the Hazard Communication Standard as distinct from that relating to this standard, OSHA has added three clarifying statements regarding laboratory-generated chemical substances. First, if a chemical substance whose chemical composition is known is produced in the laboratory for its own exclusive use, OSHA requires that available hazard information be provided to employees who may be exposed to the substance. M5DS and label preparations as required under the Hazard Communication Standard do not apply since, still qualifying under the laboratory use and laboratory scale definitions, the laboratory remains covered by this standard and is thus exempted from those requirements of the HCS. Second, employers who produce a chemical byproduct whose composition is unknown shall make the assumption that the substance is hazardous and require that it be handled according to the Chemical Hygiene Plan in paragraph (e) which provides for appropriate employee protection for hazardous chemicals. OSHA believes that in this particular case, if the hazardous properties of a chemical substance are unknown, the most prudent approach Jo employee protection is to handle the material as if it were known to be vvv 0000U1T3 3326 Federal Register / Vol. 55, No. 21 / Wednesday, January 31. 1990 / Rules and Regulations hazardous. By following this approach, the employer will not be.required to conduct literature searches or perform actual tests to evaluate the hazard. Finally, the standard clarifies the employer's responsibility where a chemical is produced in the laboratory and shipped to another user outside of the laboratory. With respect to the substance produced, the employer has become a manufacturer and therefore is subject to all the relevant provisions of the Hazard Communication Standard including requirements for the development of a material safety data sheet and labeling. However, if. manufacturing is not the laboratory's principal concern, the laboratory standard remains in effect for those activities unrelated to the manufacturing operations. Regarding shipment of waste materials, the Hazard Communication requirement will not apply in any case. Any requirement under EPA regulations regarding waste disposal will, of course, continue to apply. However. OSHA regards waste disposal by a laboratory to be a normal laboratory function. Thus, the Hazard Communication Standard will not apply as it would in the case of a substance which would be produced for and shipped to another organization. Paragraph (i). Use ofRespirators This provision requires that any use of respirators which is necessary to maintain exposures below PELs must comply with the requirements in the respiratory protection standard, 29 CFR 1910.134. Consistent with other OSHA health standards, any necessary respiratory equipment must be provided without cost to employees. These provisions do not impose any new requirements oh laboratory employers, but are included here to remind the employer of the existing compliance duty. Paragraph (j). Recordkeeping Section 8(c) of the Act authorizes the promulgation of regulations to make, keep and preserve such records regarding the employer's activities relating to the Act as are necessary or appropriate for the enforcement of the Act or for the development of information regarding the causes and prevention of occupational illnesses. The information currently before OSHA indicates that exposure monitoring and medical records prescribed herein are necessary and appropriate to both the enforcement of the standard and the development of information regarding the causes and prevention of workplace illnesses. OSHA received only minimal comment regarding the recordkeeping requirements included in the proposed standard. One comment, (Ex. 8-104), requested clarification as to whether ail medical records or just those pertaining to the overexposure were to be retained. OSHA believes that this point is clarified in the final standard in that any medical and exposure record created in connection with the standard shall be kept in accordance with 29 CFR 1910.20. Section 1910.20 is the generic standard for access to employee medical and exposure records. Section 1910.20 provides that records must be kept for the duration of employment plus 30 years and has detailed provisions for the transfer of records. OSHA has access to both medical and exposure records, subject to the Agency rules at 29 CFR 1913.10. An extensive discussion of the provisions and rationale for 1910.20 can be found in the Federal Register of September 29,1988 (53 FR 38140). Paragraph (k). Effective Date The final rule becomes effective 90 days following publication in the Federal Register. The standard provides a start-up date. The completion of preparation and implementation of the Chemical Hygiene Plan is not required until one year after the publication date. The Agency received only minimal comments on the effective date and start-up date included in the proposed standard. Several commenters agreed that the time intervals were appropriate, (see, e.g., Exs. 5-38 and 5-65). Others, however, felt that a longer start-up interval of up to two years was necessary, but provided no persuasive arguments (Exs. 8-33, 8-53, 8-91. and 8111). OSHA has carefully reviewed the provisions of the standard in terms of the length of time that would be required for employers to come into full compliance. Many employers have already instituted or are in the process of developing employee protection programs for which only minor modifications may be necessary to achieve compliance with this standard. OSHA believes that the effective date and start-up date set by the standard are reasonable and sufficient for all affected employers, including those beginning a new program, to become familiar with the contents of the preamble, standard and appendices and to complete and implement the Chemical Hygiene Plan. Paragraph (I). Appendices Two appendices are included in the final standard. The primary purpose of these appendices is to provide guidance to the employer in developing and implementing an appropriate Chemical Hygiene Plan. Appendix A is a distillation of pertinent parts of "Prudent Practices for Handling Hazardous Chemicals in Laboratories." Appendix B is a list of references which may be helpful to the employer in developing a Chemical Hygiene Plan. None of the statements in the appendices should be construed as establishing any mandatory requirements which are not otherwise imposed by the standard. Minor changes have been made in some instances to the appendices in the final rule. These changes reflect certain suggestions made by commenters (see, e.g., Exs. 8-19. 8-107) to improve the clarity of the information presented. VII. Federalism and State Plan Applicability This standard has been reviewed in accordance with Executive Order 12612. 52 FR 41885 (October 30,1987), regarding Federalism, This Order requires that agencies, to the extent possible, refrain from limiting state policy options, consult with States prior to taking any actions that would restrict State policy options, and take such actions only when there is clear constitutional authority and the presence of a problem of national scope. The Order provides for preemption of State law only if there is a clear Congressional intent for the agency to do so. Any such preemption is to be limited to the extent possible. Section 18 of the Occupational Safety and Health Act (OSH Act), expresses Congress' clear intent to preempt State laws with respect to which Federal OSHA has promulgated occupational safety or health standards. Under the OSH Act a State can avoid preemption only if it submits, and obtains Federal approval of, a plan for the development of such standards and their enforcement. Occupational safety and health standards developed by such Plan-States must, among other things, be at least as effective as the Federal standards in providing safe and healthful employment and places of employment In short, there is a clear national problem related to occupational safety and health for employees exposed to hazardous chemicals in laboratories. Those States which have elected to participate under section 18 of the OSH Act would not be preempted by this regulation and would be able to deal with special, local conditions within the framework provided by this performance-oriented standard while VVV 000011174 Federal Register / Vol. 55, No. 21 / Wednesday, January 31. 1990 / Rules and Regulations 3327 ensuring that theirstandards are at least as effective as the Federal standard. The 25 States with their"own OSHA- approved occupational safety and health plans must adopt a comparable ~ standard within six months of publication of a final rule. The States are: Alaska, Arizona, California, Connecticut Hawaii. Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, New York, North Carolina. Oregon, Puerto Rico. South Carolina, Tennessee, Utah, . - Vermont, Virginia, Virgin Islands, Washington, Wyoming. For New York - and Connecticut plans cover only state and local government employees. Until such time as a State standard is promulgated. Federal OSHA will .- provide interim enforcement assistance, as appropriate, in these States. VIII. Authority and Signature ' ' This document was prepared under the direction of Gerard F. Scanneli, Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210. Pursuant to sections 6(b) and 8(c) and of the Act, OSHA hereby amends 29 CFR part-1910 by adding a new 1910.1450 as set forth below. List of Subjects in 29 CFR Part 1910 Laboratories, Occupational safety and health. Signed at Washington, DC, this 22nd day of January 199a Gerard F. ScanneU, Assistant Secretary for OccupationalSafety and Health. Part 1910 of title 29 of the Code of Federal Regulation (CFR) is hereby amended as follows: PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS 1. The authority citation for part 1910, subpart Z is amended by adding the following citation at the end. (Citation which precedes asterisk indicates general rulemaking authority.) Authority: Secs. 8 and 8. Occupational Safety and Health Act. 29 U.S.C. 655, 657; Secretary of Labor's Orders Nos. 12-71 (39 FR 8754). &-78 (41 FR 25059). or 9-83 (48 FR 35736), as applicable; end 29 CFR part 1911. * * Section 1910.1450 is also issued under see. 6(b). 8(c) and 6(g)(2). Pub. L 91-590.84Stat. 1593,1599,1600; 29 UJS.C. 655. 657. 2. Section 1910.1450 is added to subpart Z, part 1910 to read as follows: $191.1450 Occupational exposure to hazardous chemicals in laboratories. (a) Scape and application, (l) This section shall apply to all employers engaged in the laboratory use of hazardous chemicals as defined below. (2) Where this section applies, it shall supersede, for laboratories, the requirements of all other OSHA health standards in 29 CFR part 1910. subpart Z, except as follows: .. . ._ (i) For any OSHA health standard, only the requirement to limit employee exposure to the specific permissible exposure limit shall apply for laboratories, unless that particular standard states otherwise or unless the conditions of paragraph (a)(2)(iii) of this section apply. ., ~ (ii) Prohibition of eye and skin contact where specified by any OSHA health standard shall be observed. (iii) Where the action level (or in the absence of an action level, the permissible exposure limit) is routinely exceeded for an OSHA regulated substance with exposure monitoring and medical surveillance requirements, paragraphs (d) and [g)(l)(iij of this section shall apply. (3) This section shall not apply to: (i) Uses of hazardous chemicals which do not meet the definition of laboratory use, and in such cases, the employer shall comply with the relevant standard in 29 CFR part 1910, subpart 2, even if such use occurs in a laboratory. (ii) Laboratory uses of hazardous chemicals which provide no potential for employee exposure. Examples of such conditions might include: (A) Procedures using chemically- impregnated test media such as Dip- and-Read tests where a reagent strip is dipped into the specimen to be tested and the results are interpreted by comparing the color reaction to a color chart supplied by the manufacturer of the test strip; and - (5) Commercially prepared kits such as those used in performing pregnancy tests in which all of the reagents needed to conduct the test are contained in the kit. (b) Definitions-- "Action lever' means a concentration designated in 29 CFR part 1910 for a specific substance, calculated as an eight (8)-hour time-weighted average, which initiates certain required activities such as exposure monitoring and medical surveillance. "Assistant Secretary' means the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, or designee. "Carcinogen" (see "select carcinogen"). "Chemical Hygiene Office?' means an employee who is designated by the employer, and who is qualified by training or experience, to provide technical guidance in the development and implementation of the provisions of the Chemical Hygiene Plan. This definition is not intended to place limitations on the position description or job classification that the designated indvidual shall hold within the employer's organizational structure. "Chemical Hygiene Plan" means a written program developed and implemented by the employer which sets forth procedures, equipment, personal protective equipment and work practices that (i) are capable-of protecting employees from the health hazards presented by hazardous chemicals used in that particular workplace and (ii) meets the requirements of paragraph (e) of this section. . "Combustible liquid' means any liquid having a flashpoint at or above 100 *F (37.8 `C). but below 200 "F (93.3 *C)P except any mixture having components with flashpoints of 200 F (93.3 *C), or higher, the total volume of which make up 99 percent or more of the total volume of the mixture. "Compressedgas" means: (i) A gas or mixture of gases having, in a container, an absolute pressure exceeding 40 psi at 70 *F (21.1 *C); or (ii) A gas or mixture of gases having, in a container, an absolute pressure exceeding 104 psi at 130 *F (54.4'C) regardless of the pressure at 70 *F (21.1 'C); or (iii) A liquid having a vapor pressure exceeding 40 psi at 100 'F (37.8 C) as determined by ASTM D-323--72. "Designated area." means an area which may be used for work with "select carcinogens," reproductive toxins or substances which have a high degree of acute toxicity. A designated area may be the entire laboratory, an area of a laboratory or a device such as a laboratory hood. "Emergency means any occurrence such as, but not limited to. equipment failure, rupture of containers or failure of control equipment which results in an uncontrolled release of a hazardous chemical into the workplace. "Employee" means an individual employed in a laboratory workplace who may be exposed to hazardous chemicals in the course of his or her assignments. "Explosive" means a chemical that causes a sudden, almost instantaneous release of pressure, gas, and heat when subjected to sudden shock, pressure, or high temperature. "Flammable" means a chemical that falls into one of the following categories: (i) "Aerosol flammable** means an aerosol that when tested by the method described in 16 CFR 1500.45, yields a VVV 000011175 3328 Federal Register / Vol. 55. No. 21 / Wednesday, January 31. 1990 / Rules and Regulations flame protection exceeding 18 inches at "Hazardous chemical" means a (iii) The procedures involved are not full vaive opening, or a flashback (a chemical for which there is statistically part of a production process, nor in any flame extending back torthe'Valve) at significant evidence based on at least way simulate a production process: and any degree of valve opening; one study conducted in accordance with (iv) "Protective laboratory practices (ii) "Gas, flammable" means: * established scientific principles that and equipment" are available and in (A) A gas that at ambient acute or chronic health effects may common use to minimize the potential temperature and pressure, forms a occur in exposed employees. The term for employee exposure to hazardous flammable mixture with air at a "health hazard" includes chemicals ( chemicals. . concentration of 13 percent by volume which are carcinogens, toxic or highly "Medical consultation" means a or less; or toxic agents, reproductive toxins, consultation which takes place between (B) A gas that, at ambient temperature irritants, corrosives, sensitizers, an employee and a licensed physician and pressure, forms a range of hepatotoxins, nephrotoxins, for the purpose of determining what flammable mixtures with air wider than neurotoxins, agents which act on the medical examinations or procedures, if - 12 percent by volume, regardless of the hematopoietic systems, and agents any, are appropriate in cases where a lower limit . which damage the lungs, skin, eyes, or significant exposure to a hazardous (iii) "Liquid, flammable" means any mucous membranes. chemical may have taken place. liquid having a flashpoint below 100 *F (37.8 *C), except any mixture having components with flashpoints of 100 *F (374J *C) or higher, the total of which make up 99 percent or more of the total volume of the mixture. (iv) "Solid, flammable" means a solid, other than a blasting agent or explosive as defined in 11910.109(a), that is liable to cause fire through friction, absorption of moisture, spontaneous chemical change, or retained heat from manufacturing or processing, or which can be ignited readily and when ignited bums so vigorously and persistently as Appendices A and B of the Hazard "Organicperoxide"means anorganic Communication Staadard (29 CFR compound that contains the bivalent 1910.1200) provide further guidance in --O--O--structure and which may be defining the scope of health hazards and considered to be a structural derivative determining whether or not a chemical of hydrogen peroxide where one or both is to be considered hazardous for of the hydrogen atoms has been purposes of this standard. replaced by an organic radical. "Laboratory" means a facility where the "laboratory use of hazardous chemicals" occurs. It is a workplace where relatively small quantities of hazardous chemicals are used on a nonproduction basis. "Laboratory scale" means work with "Oxidizer" means a chemical other than a blasting agent or explosive as . defined in $ 1910.109(a), that initiates or promotes combustion in other materials, thereby causing fire either of itself or through the release of oxygen or other gases. to create a serious hazard. A chemical ` substances in which the containers used "Physical hazard" means a chemical . shall be considered to be a flammable for reactions, transfers, and other ... for which there is scientifically valid solid if, when tested by the method handling of substances are designed to evidence that it is a combustible liquid, described in 16 CFR 1500.44, it ignites be easily and safely manipulated by one a compressed gas, explosive, flammable, and bums with a self-sustained flame at person. "Laboratory scale" excludes ~ I an organic peroxide, an oxidizer, a rate greater than one-tenth of an inch -those workplaces whose function is to | pyrophoric/unstable (reactive) or water- per second along its major axis. produce commercial quantities of reactive. . "Flashpoint"means the minimum materials. ' "Protective laboratory practices and. temperature at which a liquid gives off a . vapor in sufficient concentration to ignite when tested as follows: (i] Tagtiabue Closed Tester (See American National Standard Method of Test for Flash Point by Tag Closed Tester, Zll.24-1979 (ASTM D 50-79))-for liquids with a viscosity of less than 45 Saybolt Universal Seconds (SUSJ at 100 *F (37.8 *C), that do not contain suspended solids and do not have a tendency to form a surface film under test: or f"Laboratory-type hood''means a device located in a laboratory, enclosure on five sides with a moveable sash or fixed partial enclosed on the remaining side: constructed and maintained to draw air from the laboratory and to prevent or minimize the escape of air contaminants into the laboratory; and allows chemical manipulations to be equipment" means those laboratory I procedures, practices and equipment l accepted by laboratory health and I safety experts as effective, or that the 1 employer can show to be effective, in fl minimizing the potential for employee 11 exposure to hazardous chemicals. "Reproductive toxins" means chemicals which affect the reproductive conducted in the enclosure without capabilities including chromosomal insertion of any portion of the damage (mutations) and effects on employee's body other than hands and fetuses (teratogenesis) arms. "Select carcinogen " means any (ii) Pensky-Martens Closed Tester (see American National Standard Method of Test for Flash Point by Pensky-Martens Closed Tester, 211.7-1979 (ASTM D 9379)}-for liquids with a viscosity equal to or greater than 45 SUS at 100 *F (37.8 *C), or that contain suspended solids, or that have a tendency to form a surface film under test: or (lii) Setaflash Closed Tester (see American National Standard Method of Test for Flash Point by Setaflash Closed Tester (ASTM D 3278-78)). Walk-in hoods with adjustable sashes meet the above definition provided that substance which meets one of the . following criteria: the sashes are adjusted during use so (i) It is regulated by OSHA as a that the airflow and the exhaust of air carcinogen; or contaminants are not compromised and (ii) It is listed under the category, employees do not work inside the enclosure during the release of airborne hazardous chemicals. "Laboratory use ofhazardous * chemicals" means handling or use of ' such chemicals in which all of the : following conditions are met* "known to be carcinogens," in the Annual Report on Carcinogens published by the National Toxicology Program (NTP) (latest edition): or (iii) It is listed under Croup l ("carcinogenic to humans") by the International Agency for Research on Cancer Monographs (IARC) (latest Organic peroxides, which undergo | (i) Chemical manipulations are carried) editions): or autoaccelerating thermal decomposition, j out on a "laboratory scale;" ' (iv) It is listed in either Group 2A or are excluded from any of the flashpoint | (ii) Multiple chemical procedures or > 2B by IARC or under the category, determination methods Specified above. : chemicals are used; "reasonably anticipated to be WV 0000X1176 Federal Register / Vol. 55, No. 21 / Wednesday, January 31. 1990 / Rules and Regulations 3329 carcinogens" by NTP, and causes (ij Capable of protecting employees statistically significant-tumor incidence from health hazards associated with in experimental animals in accordance hazardous chemicals in that laboratory with any of the following criteria: - and (A) After inhalation exposure of 6-7 (ii) Capable of keeping exposures . hours per day, 5 days per week, for a below the limits specified in paragraph significant portion of a lifetime to (c) of this section. dosages of less than 10 mg/m3; (B) After repeated skin application of less than 300 (mg/kg of body weightj per week; or (C) After oral dosages of less than 50 mg/kg of body weight per day. "Unstable (reactive)"means a chemical which is the pure state, or as produced or transported, will vigorously polymerize, decompose, condense, or wiil become seif-reactive under conditions of shocks, pressure or temperature. "Water-reactive" means a chemical that reacts with water to release a gas that is either flammable or presents a health hazard. (c) Permissible exposure limits. For laboratory uses of OSHA regulated substances, the employer shall assure that laboratory employees' exposures to such substances do not exceed the permissible exposure limits specified in 29 CFR part 1910, subpart Z. (d) Employee exposure determination--(1j Initial monitoring. The employer shall measure the employee's exposure to any substance regulated by a standard which requires monitoring if there is reason to believe that exposure levels for that substance routinely exceed the action level (or in the absence of an action level, the PEL}. (2) Periodic monitoring. If the initial (2).The Chemical Hygiene Plan shall be readily available to employees, employee representatives and, upon request, to the Assistant Secretary. (3) The Chemical Hygiene Plan shall include each of the following elements and shall indicate specific measures that the employer will take to ensure laboratory employee protection: (i) Standard operating procedures relevant to safety and health considerations to be followed when laboratory work involves the use of hazardous chemicals; (ii) Criteria that the employer will use to determine and implement control measures to reduce employee exposure to hazardous chemicals including engineering controls, the use of personal protective equipment and hygiene practices; particular attention shall be given to the selection of control measures for chemicals that are known to be extremely hazardous; (Hi) A requirement that fume hoods and other protective equipment are functioning properly and specificmeasures that shall be taken to ensureproper and adequate performance of such equipment; (iv) Provisions for employee information and training as prescribed . in paragraph (f) of this section; monitoring prescribed by paragraph (v) The circumstances under which a (d)(1) of this section discloses employee particular laboratory operation, exposure over the action level (or in the procedure or activity shall require prior absence of an action level, the PEL), the approval from the employer or the . employer shall immediately comply with employer's designee before the exposure monitoring provisions of implementation; the relevant standard. (vi) Provisions for medical (3) Termination of monitoring. - consultation and medical examinations Monitoring may be terminated in in accordance with paragraph (g) of this accordance with the relevant standard. section; (4) Employee notification of (vii) Designation of personnel monitoring results. The employer shall, responsible for implementation of the within 15 working days after the receipt Chemical Hygiene Plan including the of any monitoring results, notify the assignment of a Chemical Hygiene employee of these results in writing Officer and. if appropriate, either individually or by posting results establishment of a Chemical Hygiene in an appropriate location that is Committee; and accessible to employees. (viii) Provisions for additional (e) Chemical hygiene plan--General. employee protection for work with (Appendix A of this section is non- particularly hazardous substances. mandatory but provides guidance to These include "select carcinogens," assist employers in the development of reproductive toxins and substances the Chemical Hygiene Plan.) (l) Where which have a high degree of acute hazardous chemicals as defined by this toxicity. Specific consideration shall be standard are used in the workplace, the given to the following provisions which employer shall develop and carry out shall be included where appropriate: the provisions of a written Chemical (A) Establishment of a designated Hygiene Plan which is: area; (B) Use of containment devices such as fume hoods or glove boxes: (C) Procedures for safe removal of contaminated waste; and (D) Decontamination procedures. (4) The employer shall review and evaluate the effectiveness of the Chemical Hygiene Plan at least annually and update it as necessary. (0 Employee information and training. (1) The employer shall provide employees with information and training to ensure that they are apprised of the hazards of chemicals present in their work area. (2) Such information shall be provided at the time of an employee's initial assignment to a work area where hazardous chemicals are present and prior to assignments involving new exposure situations. The frequency of refresher information and training shall be determined by the employer. (3) Information. Employees shall be informed of: - (ij The contents of this standard and its appendices which shall be made available to employees; (ii) The location and availability of the employer's Chemical Hygiene Plan: (iii) The permissible exposure limits for OSHA regulated substances or recommended exposure limits for other hazardous chemicals where there is no applicable OSHA standard; (iv) Signs and symptoms associated with exposures to hazardous chemicals used in the laboratory: and (v) The location and availability of known reference material on the hazards, safe handling, storage and disposal of hazardous chemicals found in die laboratory including, but not limited to. Material Safety Data Sheets received from the chemical supplier. (4) Training, (i) Employee training shall include: (A) Methods and observations that may be used to detect the presence or release of a hazardous chemical (such as monitoring conducted by the employer, continuous monitoring devices, visual appearance or odor of hazardous chemicals when being released, etc.); (B) The physical and health hazards of chemicals in the work area: and (C) The measures employees can take to protect themselves from these hazards, including specific procedures the employer has implemented to protect employees from exposure to hazardous chemicals, such as appropriate work practices, emergency procedures, and personal protective equipment to be used. vvv 000011177 3330 Federal Register / Vol. 55, No. 21 j Wednesday. January 31, 1990 / Rules and Regulations (til The employee shall be trained on the applicable details of the employer's written Chemical Hygiene Plan. (g) Medical consultation and medical examinations. {1] The employer shall provide all employees who work with hazardous chemicals an opportunity to receive medical attention, including any follow-up examinations which the examining physician determines to be necessary, under the following circumstances: () Whenever an employee develops signs or symptoms associated with a hazardous chemical to which the employee may have been exposed in the laboratory, the employee shall be provided an opportunity to receive an appropriate medical examination. (ii) Where exposure monitoring reveals an exposure level routinely above the action level (or in the absence of an action level, the PEL) for an OSHA regulated substance for which there are exposure monitoring and medical surveillance requirements, medical surveillance shall be established for the affected employee as prescribed by the particular standard. (iii) Whenever an event takes place in the work area such as a spill, leak, explosion or other occurrence resulting in the likelihood of a hazardous exposure, the affected employee shall be provided an opportunity for a medical consultation. Such consultation shall be for the purpose of determining the need for a medical examination. (2) All medical examinations and consultations shall be performed by or under the direct supervision of a licensed physician and shall be provided without cost to the employee, without loss of pay and at a reasonable time and place. (3) Information provided to the ., physician. The employer shall provide the following information to the physician: (i) The identity of the hazardous cheraical(s) to which the employee may have been exposed; (ii) A description of the conditions under which the exposure occurred including quantitative exposure data, if available: and (iii) A description of the signs and symptoms of exposure that the employee is experiencing, if any. (4} Physician's written opinion, (i) For examination or consultation required under this standard, the employer shall obtain a written opinion from the examining physician which shall include the following: (A) Any recommendation for further medical follow-up; (6) The results of the medical examination and any associated tests: (C) Any medical condition which may be revealed in the course of the examination which may place the 'employee at increased risk as a result of exposure to a hazardous chemical found in the workplace; and (D) A statement that the employee has been informed by the physician of the results of the consultation or medical examination and any medical condition that may require further examination or treatment (ii) The written opinion shall not reveal specific findings of diagnoses unrelated to occupational exposure, (h) Hazard identification, (l) With respect to labels and material safety data sheets: (i) Employers shall ensure that labels on incoming containers of hazardous chemicals are not removed or defaced. (ii) Employers shall maintain any material safety data sheets that are received with incoming shipments of hazardous chemicals, and ensure that they are readily accessible to laboratory employees. (2J The following provisions shall apply to chemical substances developed in the laboratory: . (i) If the composition of the chemical substance which is produced exclusively for the laboratory's use is known, the employer shall determine if ' it is a hazardous chemical as defined in paragraph (b) of this section. If the chemical is determined to be hazardous, the employer shall provide appropriate training as required under paragraph (f) of this section. (ii) If the chemical produced is a byproduct whose composition is not known, the employer shall assume that the substance is hazardous and shall implement paragraph (e) of this section. (iii) If the chemical substance is produced for another user outside of the laboratory, the employer shall comply with the Hazard Communication Standard (29 CFR 1910.1200) including the requirements for preparation of material safety data sheets and labeling. (i) Use ofrespirators. Where the use of respiratore is necessary to maintain exposure below permissible exposure limits, the employer shall provide, at no cost to the employee, the proper respiratory equipment. Respirators shall be selected and used in accordance with the requirements of 29 CFR 1910.134. (j) Recordkeeping. (1) The employer shall establish and maintain for each employee an accurate record of any measurements taken to monitor employee exposures and any medical consultation and examinations including tests or written opinions required by this standard. (2) The employer shall assure that such records are kept, transferred, and made available in accordance with 29 CFR 1910.20. (k) Dates--(1) Effective date. This section shall become effective May 1, 1990. (2) Start-up dates, (i) Employers shall have developed and implemented a written Chemical Hygiene Plan no later than January 31.1991. (ii) Paragraph (a)(2) of this section shall not take effect until the employer has developed and implemented a written Chemical Hygiene Plan. (l) Appendices. The information contained in the appendices is not intended, by itself, to create any additional obligations not otherwise imposed or to detract from any existing obligation. Appendix A to f 1910.1450--National Research Council Recommendations Pnnrgrmwg Chemical Hygiene in Laboratories (Non-Mandatory) Table of Contents Foreword Corresponding Sections of the Standard and This Appendix A. Generai Principles 1. Minimize all Chemical Exposures 2. Avoid Underestimation of Risk 3. Provide Adequate Ventilation 4. Institute a Chemical Hygiene Program 5. Observe the PELs and TLVs B. Responsibilities 1. Chief Executive Officer 2. Supervisor of Administrative Unit 3. Chemical Hygiene Officer 4. Laboratory Supervisor 5. Project Director 6. Laboratory Worker C. The Laboratory Facility 1. Design 2. Maintenance 3. Usage 4. Ventilation D. Components ofthe Chemical Hygiene Plan 1. Basic Rules and Procedures 2. Chemical Procurement Distribution, and Storage 3. Environmental Monitoring 4. Housekeeping. Maintenance and Inspections 5. Medical Program' 6. Personal Protective Apparel and Equipment 7. Records 8. Signs and Labels 9. Spills and Accidents 10. Training and Information 11. Waste Disposal E- General Procedures for Working With Chemicals 1. General Rules for all Laboratory Work with Chemicals 2. Allergens and Embryotoxins OOOOH^ Federal Register / Vol. 55. No. 21 / Wednesday, January 31, 1990 / Rules and Regulations 3331 3. Chemicals of Moderate Chronic or High Acute Toxicity 4. Chemicals of High Chronic Toxicity 5. Animal Work with Chemicals of High Chronic Toxicity F. Sofety Recommendations G. Material Safety Data Sheets Foreword As guidance for each employer's deveiopment of an appropriate laboratory Chemical Hygiene Plan, the following non mandatory recommendations are provided. They were extracted from "Prudent Practices for Handling Hazardous Chemicals in Laboratories" (referred to below as "Prudent Practices"), which was published In 1981 by the National Research Council and is available from the National Academy Press, 2101 Constitution Ave., NW., Washington DC 20418. "Prudent Practices" is cited because of its wide distribution and acceptance and because of its preparation by members of the laboratory community through the sponsorship of the National Research Council. However, none of the recommendations given here will modify any requirements of the laboratory standard. This Appendix merely presents pertinent recommendations from "Prudent Practices", organized into a form convenient for quick reference during operation of a laboratory facility and during development and application of a Chemical Hygiene Plan. Users of this appendix should consult "Prudent Practices" for a more extended presentation and justification for each . recommendation. "Prudent Practices" deals with both safety and chemical hazards while the laboratory . standard is concerned primarily with chemical hazards. Therefore, only those recommendations directed primarily toward control of toxic exposures are cited in this appendix, with the term "chemical hygiene" being substituted for the word "safety". However, since conditions producing or threatening physical injury often pose toxic risks as well, page references concerning major categories of safety hazards in the laboratory are given in section F. The recommendations from "Prudent Practices" have been paraphrased, combined, or otherwise reorganized, and headings have been added. However, their sense has not been changed. . Corresponding Sections ofthe Standard and this Appendix The following table is given for the convenience of those who are developing a Chemical Hygiene Plan which will satisfy the requirements of paragraph (e) of the standard. It indicates those sections of this appendix which are most pertinent to each of the sections of paragraph (e) and related paragraphs. Paragraph and took: in laboratory standard Relevant appendix section (e)(3)(i) Standard operating procedures C. 0, E for handling toxic chemicals. (e)(3)(H) Criteria to be used for imple 0 mentation of measures to reduce ex posures. (e)<3)(iii) Fume hood performance ^ C4b (e|(3Ktv) Employee information and DIO, D9 training (including emergency proce dures). (e)(3)(v) Reauirements for prior ap E2b. E4b proval ot laboratory activities. (e)<3)(vi) Medical consultation and 05. E4 medical examinations. (e)(3)(vit) Chemical hygiene response B bilities. (e)(3)(viii) Special precautions tor work E2, E3. with particularly hazardous sub stances. E4 In this appendix, those recommendations directed primarily at administrators and supervisors are given in sections A-D. Those recommendations of primary concern to employees who are actually handling laboratory chemicals are given in section E. (Reference to page numbers in "Prudent Practices" are given in parentheses.) A. GeneralPrinciples for Work with Laboratory Chemicals In addition to the more detailed recommendations listed below in sections BE. "Prudent Practices" expresses certain general principles, including the following: 1. It is prudent to minimize all chemical exposures. Because few laboratory chemicals are without hazards, general precautions for handling all laboratory chemicals should be adopted, rather than specific guidelines for particular chemicals (2,10). Skin contact with chemicals should be avoided as a cardinal rule (198). 2. Avoid underestimation ofrisk. Even for substances of no known significant hazard, exposure should be minimized; for work with substances which present special hazards, special precautions should be taken (10, 37, 38]. One should assume that any mixture will be more toxic than its most toxic component (30,103) and that all substances of unknown toxicity are toxic (3, 34]. 3. Provide adequate ventilation. The best way to prevent exposure to airborne substances is to prevent their escape into the working atmosphere by use of hoods and other ventilation devices (32.196). 4. Institute a chemical hygiene program. A mandatory chemical hygiene program designed to minimize exposures is needed: it should be a regular, continuing effort, not merely a standby or short-term activity (8, 11). Us recommendations should be followed in academic teaching laboratories as well as by full-time laboratory workers (13). 5. Observe the PELs, TL Vs. The Permissible Exposure Limits of OSHA and the Threshold Limit Values of the American Conference of Governmental Industrial Hygienists should not be exceeded (13). B. Chemical Hygiene Responsibilities Responsibility for chemical hygiene rests at all levels (6.11. 21] including the: 1. Chief executive officer, who has ultimate responsibility for chemical hygiene within the institution and must, with other administrators, provide continuing support for institutional chemical hygiene (7,11], 2. Supervisor of the department or other administrative unit, who is responsible for chemical hygiene in that unit (7]. 3. Chemical hygiene officer(s). whose appointment is essential (7) and who must: (a) Work with administrators and other employees to develop and implement appropriate chemical hygiene policies and practices (7); (b) Monitor procurement use. and disposal of chemicals used in the lab (8); (c) See that appropriate audits are maintained (8); (d) Help project directors develop precautions and adequate facilities (10); (ej Know the current legal requirements concerning regulated substances (50]-. and (f] Seek ways to improve the chemical hygiene program (8,11]. A. Laboratory supervisor,-who has overall responsibility for chemical hygiene in the laboratory (21) including responsibility to: (a) Ensure that workers know and follow the chemical hygiene rules, that protective equipment is available and in working order, and that appropriate training has been provided (21, 22); (b) Provide regular, formal chemical hygiene and housekeeping inspections including routine inspections of emergency equipment (21,171); (c) Know the current legal requirements concerning regulated substances (50, 231): (d) Determine the required levels of protective apparel and equipment (156,160, 162); and (e) Ensure that facilities and training for use of any material being ordered are adequate (215). 5. Project director or director ofother specific operation, who has primary responsibility for chemical hygiene procedures for that operation (7). 6- Laboratory worker, who is responsible for (a) Planning and conducting each operation in accordance with the institutional chemical hygiene procedures (7. 21. 22. 230); and (b) Developing good personal chemical hygiene habits (22). C. The Laboratory Facility 1. Design. The laboratory facility should have: (a) An appropriate general ventilation system (see C4 below) with air intakes and exhausts located so as to avoid intake of contaminated air (194); (b) Adequate, well-ventilated stockrooms/ storerooms (218. 219); (c) Laboratory hoods and sinks (12.162); (d) Other safety equipment Including eyewash fountains and drench showers (162. 169); and (e) Arrangements for waste disposal (12. 240). vw 000011179 3332 Federal Register / Vol. 55. No. 21 / Wednesday. January 31, 1990 / Rules and Regulations 2. Maintenance. Chemicai-hvgiene-reiated equipment (hoods, incinerator, etc.) should undergo continuing appraisal and be modified if inadequate (11.12). 3. Usage. The work conducted (10) and its scale (12) must be appropriate to the physicial facilities available and. especially, to the quality of ventilation (13). 4. Ventilation--(a) General laboratory ventilation. This system should: Provide a source of air for breathing and for input to local ventilation device* (199); it should not be relied on for protection from toxic substances released into the laboratory (198): ensure that laboratory air is continually replaced, preventing increase of air concentrations of toxic substances during the working day (194); direct air flow into the laboratory from non-laboratory areas and ont to the exterior of the building (194). (b) floods. A laboratory hood with Z5 linear feet of hood space per person should be provided For every Z workers if they spend most of their time working with chemicals (199); each hood should have a continuous monitoring device to eflow convenient confirmation of adequate hood performance before use (200.209). If this is not possible, work with substances of unknown toxicity should be avoided (13) or other types of local ventilation devices should be provided (199). See pp. 201-206 for a discussion of hood design, construction, and evaluation. (c) Other local ventilation devices. Ventilated storage cabinets, canopy hoods, snorkels, etc. should be provided as needed (199). Each canopy hood and snorkel should have a separate exhaust duct (207). (d) Special ventilation areas. Exhaust air from glove boxes and isolation rooms should be passed through scrubbers or other treatment before release into the regular exhaust system (208). Cold rooms and warm rooms should have provisions for rapid escape and for escape in the event of electrical failure (209). , (e) Modifications. Any alteration of the ventilation system should be made only if thorough testing indicates that worker protection from airborne toxic substances will continue to be adequate (12.193.204). (f) Performance. Rate: 4-12 room air changes/hour is normally adequate general ventilation if local exhaust systems such aa hoods are used as the primary method of control (194). (g) Quality. General air flow should not be turbulent and should be relatively uniform throughout the laboratory, with no high velocity or static areas (194.19S): airflow into and within the hood should not be excessively turbulent (200); hood face velocity should be adequate (typically 8<M00 lfm) (200. 204). (h) Evaluation. Quality and quantity of ventilation should be evaluated on installation (202). regularly monitored [at least every 3 months) (6,12.14.195), and reevaluated whenever a change in local ventilation devices is made (12.195,207). See pp. 195-198 for methods of evaluation and far calculation of estimated airborne contaminant concentrations. D. Components of the Chemical Hygiene Plan 1. Basic Rules and Procedures (Recommendations for these are given in section E. below) 2. Chemical Procurement, Distribution, and Storage (a) Procurement. Before a substance is received information on proper handling, storage, and disposal should be known to those who will be involved (215. 216). No container should be accepted without an adequate identifying label (216). Preferably, all substances should be received in a central location (218). (b) Stockrooms/storerooms. Toxic substances should be segregated in a wellidentified area with local exhaust ventilation (221). Chemicals which are highly toxic (227) or other chemicals whose containers have been opened should be in unbreakable secondary containers (219). Stored chemicals should be examined periodically (at least annually) for replacement, deterioration, and container integrity (215-19). Stockrooms/storerooms should not be used as preparation or repackaging areas, should be open during normal working hours, and should be controlled by one person (219). (c) Distribution. When chemicals are hand carried, the container should be placed in an outside container or bucket. Freight-only elevators should be used if passible (223). (d) Laboratory storage. Amounts permitted should be as small aa practical. Storage on bench tops and in hoods is inadvisable. Exposure to heat or direct sunlight should be avoided. Periodic inventories should he conducted, with unneeded items being discarded or returned to the storeroom/ stockroom (225-6, 229). 3. Environmental Monitoring Regular instrumental monitoring of airborne concentrations is not usually justified or practical in laboratories but may be appropriate when testing or redesigning hoods or other ventilation devices (12) or when a highly toxic substance is stored or used regularly {e-g,, 3 times/week) (13). 4. Housekeeping, Maintenance, and Inspections (a) Cleaning. Floors should be cleaned regularly (24). (b) Inspections. Formal housekeeping and chemical hygiene inspections should be held at least quarterly (6. 21] for units which have frequent pesonnel changes and semiannually for others: informal inspections should be continual (21). (c) Maintenance. Eye wash fountains should be inspected at intervals of not less than 3 months (6). Respirators for routine use should be inspected periodically by the laboratory supervisor (169). Safety showers should be tested routinely (169). Other safety equipment should be inspected regularly. [e.g~ every 3--5 months) (6. 24.171). Procedures to prevent restarting of out-of- service equipment should be established (25). (d) Passageways. Stairways and hallways should not be used as storage areas (24). Access to exits, emergency equipment, and utility controls should never be blocked (24). 5. Medical Program (a) Compliance with regulations. Regular medical surveillance should be established to the extent required by regulations (12). (b) Routine surveillance. Anyone whose work involves regular and frequent handling of toxicologically significant quantities of a chemical should consult a qualified physician to determine on an individual basis whether a regular schedule of medical surveillance is desirable (11. 50). (c) First aid. Personnel trained in first aid should be available during working hours and an emergency room with medical personnel should be nearby (173). See pp. 176-178 for description of some emergency first aid procedures. 8. Protective Apparel and Equipment These should include for each laboratory: (a) Protective apparel compatible with the required degree of protection for substances being handled (156-161); (b) An easily accessible drench-type safety shower (162.169); (c) An eyewash fountain (162); (d) A fire extinguisher (162-164); (e) Respiratory protection (164-9), fire alarm and telephone for emergency use (162) should be available nearby; and (Q Other items designated by the laboratory supervisor (156,160). 7. Records (a) Accident records should be written and retained (174). (b) Chemical Hygiene Plan records should document that the facilities and precautions were compatible with current knowledge and regulations (7). (c) Inventory and usage records for highrisk substances should be kept as specified in sections E3e below. (d) Medical records should be retained by the institution in accordance with the requirements of state and federal regulations (12). 6. Signs and Labels Prominent signs and labels of the following types should be posted: (a) Emergency telephone numbers of emergency penonnel/fatilities. supervisors, and laboratory workers (28): (b) Identity labels, showing contents of containers (including waste receptacles) and associated hazards (27,48); (c) Location signs for safety showers, eyewash stations, other safety and first aid equipment, exits (27) and areas where food and beverage consumption, and storage are permitted (24); and (d) Warnings atareas or equipment where special or unusual hazards exist (27). 9. Spills and Accidents (a) A written emergency plan should be established and communicated to ail personnel; it should include procedures for ventilation failure (200). evacuation, medical care, reporting, end drills (172). (b) There should be an alarm system to alert people in all parts of the facility including isolation areas such as cold rooms (172). VVV 000011180 Federal Register / Vol. 55, No, 21 / Wednesday, January 31. 1990 / Rules and Regulations 3333 (c) A spill control policy should be developed and should includaxonsideration of prevention, containment, cleanup, and reporting (175). (d) All accidents or near accidents should ~ be carefully analyzed with the results distributed to all who might benefit (8,28). 10. Information and Training Program (a) Aim: To assure that all individuals at risk are adequately informed about the work in the laboratory, its risks, and what to do if an accident occurs (5,15). (b) Emergency and Personal Protection Training: Every laboratory worker should know the location and proper use of available protective apparel and equipment (154,169). . Some of the full-time personnel of the laboratory should be trained in the proper use of emergency equipment and procedures (6). Such training as weil as first aid instruction should be available to (154) and encouraged for (176) everyone who might need it. (c) Receiving and stockroom/storeroom personnel should know about hazards, handling equipment, protective apparel, and relevant regulations (217). (d) Frequency of Training: The training and education program should be a regular, continuing activity--not simply an annual presentation (15). (e) Litersture/Consultation; Literature and consulting advice concerning chemical hygiene should be readily available to laboratory personnel, who should be encouraged to use these information resources (14). It. Waste Disposal Program. (a) Aim: To assure that minimal harm to people, other organisms, and the environment will result from the disposal of waste laboratory chemicals (5). (b) Content (14,232, 233, 240): The waste disposal program should specify how waste is to be collected, segregated, stored, and transported and include consideration of what materials can be incinerated. Transport. from the institution must be in accordance with DOT regulations (244). (c) Discarding Chemical Stocks: Unlabeled containers of chemicals and solutions should undergo prompt disposal; if partially used, they should not be opened (24, 27). Before a worker's employment in the laboratory ends, chemicals for which that person was responsible should be discarded or returned to storage (226). (d) Frequency of Disposal; Waste should be removed from laboratories to a central waste storage area at least once per week and from the central waste storage area at regular intervals (14). (e) Method of Disposal: Incineration in an environmentally acceptable manner ia the most practical disposal method for Combustible laboratory waste (14, 236. 241). Indiscriminate disposal by pouring waste chemicals dawn the drain (14. 231. 242) or jading them to mixed refuse for landfill "urial is unacceptable (14). Hoods should not be used as a means of disposal for volatile chemicals (40.200). Disposal by recycling (233.243) or chemical decontamination (40, 230] should be used ^hen possible. E. Basic Rules and Procedures for Working times in the laboratory but do not wear with Chemicals sandals, perforated shoes, or sneakers (158). The Chemical Hygiene Plan should require (j) Personal housekeeping: Keep the work that laboratory workers know and follow its area dean and uncluttered. with chemicals rules and procedures. In addition to the and equipment being properly labeled and procedures of the sub programs mentioned above, these should include the rules listed stored: dean up the work area on completion of an operation or at the end of each day (24). below. (k) Personalprotection: Assure that 1. General Rules The following should be used for essentially all laboratory work with chemicals: (a) Accidents and spills--Eye Contact: Promptly flush eyes with waterfor a prolonged period (15 minutes) and seek medical attention (33.172). Ingestion: Encourage the victim to drink large amounts of water (178). Skin Cootact Promptly flush the affected area with water (33.172.178} and remove any contaminated clothing (172.178). If symptoms persist after washing, seek medical attention (33). appropriate eye protection (154-156) is worn by all persons, Including visitors, where chemicals are stored or handled [22. 23. 33, 154). . Wear appropriate gloves when the potential for contact with toxic materials exists (157); inspect the gloves before each use, wash them before removal, and replace them periodically (157). (A table of resistance to chemicals of common glove materials is given p. 159). Use appropriate (164-168) respiratory equipment when air contaminant concentrations are not sufficiently restricted by engineering controls (164-5), inspecting Clean-up. Promptly clean up spills, using appropriate protective apparel and the respirator before use (169). Use any other protective and emergency equipment and proper disposal (24 33}. See apparel and equipment as appropriate (22, pp. 233-237 for specific clean-up 157-182). recommendations. Avoid use of contact lenses in the lb) Avoidance of "routine" exposure: laboratory unless necessary; if they are used, Develop and encourage safe habits (23): inform supervisor so special precautions can avoid unnecessary exposure to chemicals by be taken (155). any route (23): Remove laboratory coats immediately on Do not smell or taste chemicals (32). Vent' significant contamination (181). apparatus which may discharge toxic (l) Planning: Seek information and advice chemicals (vacuum pumps, distillation columns, etc.) into local exhaust devices (199). Inspect gloves (157) and test glove boxes (208) before use. Do not allow release of toxic substances in cold rooms and warm rooms, since these have contained recirculated atmospheres (209) . (c) Choice ofchemicals: Use only those chemicals for which the quality of the available ventilation system is appropriate (13). (d) Eating, smoking, etc.: Avoid eating, drinking, smoking, gum chewing, or application of cosmetics in areas where laboratory chemicals are present (22,24.32. 40); wash hands before conducting these activities (23, 24). Avoid storage, handling or consumption of food or beverages in storage areas, refrigerators, glassware or utensils which are also used for laboratory operations (23, 24. 226). (e) Equipment andglassware; Handle and store laboratory glassware with care to avoid damage: do not use damaged glassware (25). Use extra care with Dewar flasks and other about hazards (7), plan appropriate protective procedures, and plan positioning of equipment before beginning any new operation (22, 23). (m) Unattended operations: Leave lights on, place an appropriate sign on the door, and provide for containment of toxic substances in the event of failure of a utility service (such as cooling water) to an unattended operation (27.128). (n) Use ofhood: Use the hood for operations which might result in release of toxic chemical vapors or dust (193-9). As a rule of thumb, use a hood or other local ventilation device when working with any appreciably volatile substance with a TLV of less than 50 ppm (13). Confirm adequate hood performance before use: keep hood closed at all times except when adjustments within the hood are being made (200); keep materials stored in hoods to a minimum and do not allow them to block, vents or air flow (200). Leave the hood "on" when it is not in active use if toxic substances are stored m it or if it ia uncertain whether adequate general laboratory ventilation will be maintained evacuated glass apparatus: shield or wrap when it is "off (200). them to contain chemicals and fragments (0) Vigilance: Be alert to unsafe conditions should implosion occur (25). Use equipment . and see that they are corrected when only for its designed purpose (23,26). - detected (22). (f) Exiting: Wash areas of exposed skin (p) Waste disposal: Assure that the plan well before leaving the laboratory (23). for each laboratory operation includes plans (3) Horseplay: Avoid practical jokes or and training for waste disposal (230). other behavior which might confuse, startle Deposit chemical waste in appropriately or distract anotherworker (23). ... ; labeled receptacles and follow all other (h) Mouth suction: Do not use mouth ' ' waste disposal procedures of the Chemical suction for pipeting or starting a siphon (23,. Hygiene Plan (22.24). 32). o not discharge to the sewer concentrated (i) Personal apparel: Confine long hair and acids or bases (231 k highly toxic, loose clothing (23,153). Wear shoes at all malodorous, or lachrymatory substances yw ooooinai 3334 Federal Register / Vol. 55, No. 21 / Wednesday. January 31, 1990 / Rules and Regulations (231); or any substances which might interfere with the biological activity of waste water treatment plants, create fire or explosion hazards, cause structural damage or obstruct flow (242). (q) Working alone: Avoid working alone in a building; do not work alone in a laboratory if the procedures being conducted are hazardous (28). 2. Working with Allergens and Embryotoxins (a) Allergens (examples: diazomethane, isocyanates, bichromates); Wear suitable gloves to prevent hand contact with allergens or substances of unknown allergenic activity (35). (b) Embryotoxins (34-5) (examples; ocganomercurials, lead compounds, formamide): If you are a woman of childbearing age. handle these substances only In a hood whose satisfactory performance has been confirmed, using appropriate protective apparel (especially gloves) to prevent skin contact Review each use of these materials with the research supervisor and review continuing uses annually or whenever a procedural change is made. -- Store these substances, properly labeled, in an adequately ventilated area in an unbreakable secondary container. Notify supervisors of all incidents of exposure or spills; consult a qualified physician when appropriate. 3. Work with Chemicals of Moderate Chronic or High Acute Toxicity Examples: dilaopropylflurophosphate [41], hydrofluoric acid (43). hydrogen cyanide (45). Supplemental rules to be followed in addition to those mentioned above (Procedure B of "Prudent Practices1', pp. 3941): (a) Aim: To minimize exposure to these toxic substances by any route using all reasonable precautions (39). (b) Applicability: These precautions are appropriate for substances with moderate chronic or high acute toxicity used in significant quantities (39). (c) Location: (Jse and store these substances only in areas of restricted access with special warning signs (40. 229). Always use a hood (previously evaluated to confirm adequate performance with a face velocity of at least 60 linear feet per minute) (40) or other containment device for procedures which may result in the generation of aerosols or vapors containing the substance (39); trap released vapors to prevent their discharge with the hood exhaust (40). (d) Personalprotection: Always avoid skin contact by use of gloves and long sleeves (and other protective apparel as appropriate) (39). Always wash hands and arms immediately after working with these materials (40). (e) Records: Maintain records of the amounts of these materials on hand, amounts used, and the names of the workers involved (40. 229). (f) Prevention ofspiils and accidents: Be prepared for accidents and spills (41). Assure that at least 2 people are present at all times if a compound in use is highly toxic or of unknown toxicity (39]. Store breakable containers of these substances in chemically resistant trays: also work and mount apparatus above such trays pr cover work and storage surfaces with removable, absorbent, plastic backed paper (40) . If a major spill occurs outside the hood, evacuate the area; assure that cleanup personnel wear suitable protective apparel and equipment (41). (g) Waste: Thoroughly decontaminate or incinerate contaminated clothing or shoes (41) . If possible, chemically decontaminate by chemical conversion (40). Store contaminated waste in closed, suitably labeled, impervious containers (for liquids, in glass or plastic bottles half-filled with vermiculite) (40). 4. Work with Chemicals of High Chronic Toxicity- [Examples; dimethylmercury and nickel carbonyl (48). ben20-a-pyrene (51). Nnitrosodiethylamine (54), other human carcinogens or substances with high carcinogenic potency in animals (38).) Further supplemental rules to be followed. In addition to all these mentioned above, for work with substances of known high chronic toxicity (in quantities above a few milligrams to a few grams, depending on the substance) (47) . (Procedure A of "Prudent Practices" pp. 47-50). (a) Access: Conduct all transfers and work with these substances in a "controlled area": a restricted access hood, glove box, or portion of a lab. designated for use of highly toxic substances, for which all people with ,, access are aware of the substances being used and necessary precautions (46). (b) Approvals: Prepare a plan for use and disposal of these materials and obtain the approval of the laboratory supervisor (46). (c) Non-contamination/Decontamination: Protect vacuum pumps against contamination by scrubbers or HEPA filters and vent them into the hood (49). Decontaminate vacuum pumps or other contaminated equipment including glassware, in the hood before removing them from the controlled area (49. 50). % Decontaminate the controlled area before normal work is resumed there (50). (d) Exiting: On leaving a controlled area, remove any protective apparel (placing it in an appropriate, labeled container) and thoroughly wash hands, forearms, face, and neck (49). (e) Housekeeping: Use a wet mop or a vacuum cleaner equipped with a HEPA Alter instead of dry sweeping if the toxic substance was a dry powder (50). (f) Medical surveillance: If using toxicologicaily significant quantities of such a substance on a regular basis {e.g.. 3 times per week), consult a qualified physician concerning desirability of regular medical surveillance (50). (g) Records: Keep accurate records of the amounts of these substances stored (229) and used, the dates of use. and names of users (48) . (h) Signs and labels: Assure that the controlled area is conspicuously marked with warning and restricted access signs (49) and that all containers of these substances are appropriately labeled with identity and warning labels (48). (i) Spills: Assure that contingency plans, equipment, and materials to minimize exposures of people and property in case of accident are available (233-4). (j) Storage: Store containers of these chemicals only in a ventilated, limited access (48, 227. 229) area in appropriately labeled, unbreakable, chemically resistant, secondary containers (4a 229). (k) Glove boxes: For a negative pressure glove box. ventilation rate must be at least 2 volume changes/hour and pressure at least 0-5 inches of water (48). For a positive pressure glove box. thoroughly check for leaks before each use (49). In either case, trap the exit gases or filter them through a HEPA filter and then release them into the hood (49). (l) Waste: Use chemical decontamination whenever possible; ensure that containers of contaminated waste (including washings from contaminated flasks) are transferred from the controlled area in a secondary container under the supervision of authorized personnel (49, 50, 233). 5. Animal Work with Chemicals of High Chronic Toxicity (a) Access: For large scale studies, special facilities with restricted access are preferable (56). (b) Administration ofthe toxic substance: When possible, administer the substance by injection or gavage instead of in the diet. If administration is in the diet, use a caging system under negative pressure or under laminar air flow directed toward HEPA filters (56). (c) Aerosol suppression: Devise procedures which minimize formation and dispersal of contaminated aerosols, including those from food, urine, and feces (e.g., use HEPA filtered vacuum equipment for cleaning, moisten contaminated bedding before removal from the cage, mix diets in closed containers in a hood) (55. 56). (d) Personalprotection: When working in the animal room, wear plastic or rubber gloves, fully buttoned laboratory coat or jumpsuit and. if needed'because of incomplete suppression of aerosols, other apparel and equipment (shoe and head coverings, respirator) (56). (e) Waste disposal: Dispose of contaminated animal tissues and excreta by incineration if the available incinerator can convert the contaminant to non-toxicproducts (238); otherwise, package the waste appropriately for burial in an EPA-approved site (239). F. Safety Recommendations The above recommendations from "Prudent Practices'* do not include those which are directed primarily toward prevention of physical Injury rather than toxic exposure. However, failure of precautions against . injury will often have the secondary effect of causing toxic exposures. Therefore, we list below page references for recommendations concerning Borne of the major categories of safety hazards which also have implications for chemical hygiene: 1. Corrosive agents: (35-6) vvv 000011182 Federal Register / Vol. 55, No. 21 / Wednesday, January 31, 1990 / Rules and Regulations 3335 2. Electrically powered laboratory apparatus: (1/9-92) 3. Fires, explosions: (28,57-7?, 162-4,174-5, 219-20. 226-7) 4. Low temperature procedures: (26, 88) 5. Pressurized and vacuum operations (including use of compressed gas cylinders): (27, 75-101) C. Material Safety Data Sheets Material safety data sheets are presented in "Prudent Practices'' for the chemicals listed below. (Asterisks denote that comprehensive material safety data sheets are provided). Acetyl peroxide (105) 'Acrolein (106) Acrylonitrile (107) Ammonia (anhydrous) (91) 'Aniline (109) 'Benzene (110) `Benzo(ajpyrene (112) 'Eisfchloromethvl) ether (113) Boron trichloride (91) Boron trifluoride (92) Bromine (114] 'Tert-hutyl hydroperoxide (148) `Carbon disulfide (116) Carbon monoxide (92) `Carbon tetrachloride (118) "Chlorine (119) Chlorine trifluoride (94) 'Chloroform (121) Chloromethaoe (93) `Diethyl ether (122) Diisopropyl fluorophosphate (41) `Dimethylformamide (123) `Dimethyl sulfate (125) `Dioxane (12S) 'Ethylene dibromide (128) `Fluorine (95) 'Formaldehyde (130) `Hydrazine and salts (132) Hydrofluoric acid (43) Hydrogen bromide (98) Hydrogen chloride (98) 'Hydrogen cyanide (133) 'Hydrogen sulfide (135) Mercury and compounds (52) 'Methanol (137) 'Morpholine (138) 'Nickel carbonyl (99) 'Nitrobenzene (139) Nitrogen dioxide (100) N-nitrosodiethylamine (54) 'Peracetic acid (141) 'Phenol (142) 'Phosgene (143) 'Pyridine (144) 'Sodium azide (145) 'Sodium cyanide (147) Sulfur dioxide (101) `Trichloroethylene (149) `Vinyl chloride (150) Appendix B to 9 1910.1450--References (Non-Mandatory) - The following references are provided to assist the employer in the development of a Chemical Hygiene Plan. The materials listed below are offered as non-mandatory guidance. References listed.here do not imply specific endorsement of a book, opinion, technique, policy or a specific solution for a safety or health problem. Other references not listed here may better meet the needs of a specific laboratory, (a) Materials for the development of the Chemical Hygiene Plan: 1. American Chemical Society. Safety in Academic Chemistry Laboratories, 4th edition, 1935. 2. Fawcett, H.H. and W. S. Wood. Safety and Accident Prevention in Chemical Operations. 2nd edition, Wiley-lnterscience, New York, 1982. 3. Flury, Patricia A.. Environmental Health and Safety in the Hospital Laboratory. Charles C- Thomas Publisher. Springfield IL, 1978. 3. Green, Michael E. and Turk, Amos. Safety in Working with Chemicals, Macmillan Publishing Co., NY, 1973. 5. Kaufman, James A., Laboratory Safety Guidelines. Dow Chemical Co.. Box 1713, Midland. MI 48S40.1977, 6. National Institutes of HeuLth, NIH Guidelines for the Laboratory use of Chemical Carcinogens, NIH Pub. No. 81-2365, GPO, Washington, DC 20402.1981. 7. National Research Council. Prudent Practices for Disposal of Chemicals from Laboratories. National Academy Press, Washington. DC. 1833. 8. National Research Council. Prudent Practices for Handling Hazardous Chemicals in Laboratories. Notional Academy Press. Washington, DC, 1981. 9. Renfrew, Malcolm, Ed., Safety in the Chemical Laboratory, Vol. IV,/ Chem. Ed., American Chemical Society. Easlon, PA. 1981. 10. Steere. Norman V., Ed.. Safety in the Chemical Laboratory,/. Chem. Ed. American Chemical Society, Easlon, PA, 16042. Vol. L 1967, Vol. II. 1971. Vol. Ill 1974. 11. Steere, Norman V., Handbook of Laboratory Safety, the Chemical Rubber Company Cleveland, OH. 1971. 12. Young, Jay A., Ed.. Improving Safely in the Chemical Laboratory. John Wiley & Sons, Inc. New York, 1987. (b) Hazardous Substances Information: 1. American Conference of Governmental Industrial Hygienists, Threshold Limit Values for Chemical Substances and Physical Agents in the Workroom Environment with Intended Changes, PO. Box 1937 Cincinnati. OH 45201 (latest edition), 2. Annual Report on Carcinogens. National Toxicology Program U.S. Department of Health and Human Services. Public Health Service. U.S. Government Printing Office, Washington, DC (latest edition). 3. Best Company. Best Safety Directory, Vois. i and II. Oldwick, N.J., 1931. 4. Bretherick, L, Handbook of Reactive Chemical Hazards. 2nd edition, Butterworths, London. 1979. 5. Bretherick, L., Hazards in the Chemical Laboratory. 3rd edition. Royal Society of Chemistry. London. 1988. 8. Code of Federal Regulations, 29 CFR part 1910 subpart Z. U.S. Govt. Printing Office, Washington. DC 20402 (latest edition). 7. IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man. World Health Organization Publications Center. 49 Sheridan Avenue. Albany, New York 12210 (latest editions). 8. NIOSH/OSHA Pocket Guide to Chemical Hazards. NIOSH Pub. No. 85-114. U.S. Government Printing Office. Washington. DC, 1985 (or latest edition). 9. Occupational Health Guidelines. NIOSH/OSHA NIOSH Pub. No. 81-123 U.S. Government Printing Office. Washington. DC, 1981. 10. Patty, F.A., Industrial Hygiene and Toxicology, John Wiley 4 Sons, Inc.. New York. NY (Five Volumes). 11. Registry of Toxic Effects of Chemical Substances, U.S. Department of Health and Human Services. Public Health Service, Centers for Disease Control. National Institute for Occupational Safety and Health. Revised Annually, for sale from Superintendent of Documents LT.S. Govt. Printing Office. Washington. DC 20402. 12. The Merck Index: An Encyclopedia of Chemicals and Drugs- Merck and Company Inc. Rahway. N.J., 1976 (or latest edition). 13. Sax, N.L Dangerous Properties of industrial Materials. 5th edition. Van Nostrand Reinhold. NY., 1979. 14. Sittig, Marshall, Handbook of Toxic and Hazardous Chemicals. Noyes Publications. Park Ridge, NJ, 1981. (c) Information on Ventilation: 1. American Conference of Governmental Industrial Hygienists Industrial Ventilation. 16th edition Lansing. Ml. 1980. 2- American National Standards Institute. Inc- American National Standards Fundamentals Governing the Design and Operation of Local Exhaust Systems ANSI Z 9.2-1979 American National Standards Institute, N.Y.1979. 3- Imad. A.P. and Watson, C.L. Ventilation Index: An Easy Way to Decide about Hazardous Liquids, Professional Safety pp 15-18, April 1960. 4. National Fire Protection Association. Fire Protection for Laboratories Using Chemicals NFPA-45,1982. Safety Standard for Laboratories in Health Related Institutions. NFPA. 56c. 1980. Fire Protection Guide on Hazardous Materials, 7th edition. 1978. National Firo Protection Association, Batterymorch Park. Quincy. MA 02269. 5. Scientific Apparatus Makers Association (SAMA), Standard for Laboratory Fume Hoods. SAMA LF7-1900,110116th Street. NVV., Washington. DC 20038. (d) Information on Availability of Referenced Material: 1. American National Standards Institute (ANSI). 1430 Broadway. New York. NY 10018. 2. American Society for Testing and Materials (ASTM). 1916 Race Street, Philadelphia. PA 19103. (Approved by the Office of Management and Budget under control number 1218-0131) [FR Doc. 90-1717 Filed 1-30-90; 8:45 am) SILUMQ COOe 4S10-M-M VVV 000011183